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Pfizer jobs in Rocky Mount, NC - 70 jobs

  • Formulation Tech (R3 day shift)

    Pfizer 4.5company rating

    Pfizer job in Rocky Mount, NC

    Why Patients Need You Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them. What You Will Achieve The Production Technician R3 Solutions is required to comply with Hospira policies, procedures, quality standards, Current Good Manufacturing Practices (cGMP), as well as safety and environmental regulations. The Production Technician will operate equipment that mixes active pharmaceutical ingredients, excipients and other components to specified standards following written directions from a batch record. How You Will Achieve It Responsible for the operation of production equipment, performing routine maintenance, preventative maintenance, change over's, adjustments, and repairs of production and process equipment, for the facility and/or utility equipment Responsible for weighing, measuring, and charging ingredients and inspecting solution complete dissolution. Responsible for the pre/post cleaning of all equipment necessary for batch manufacture. Responsible for maintaining proper process parameters. (i.e. mixing time, speed, temperature and any other applicable variables. Prepares tanks, cleans tanks, and area related equipment before and after solution manufacturing. Weighs drugs, cleans and sets up test filter, withdraws samples, performs some testing (ph, conductivity, oxidizable substances, etc) as needed for solution manufacture. Performs in process pH checks for solutions and makes adjustments as needed. Keeps accurate records as needed for solution manufacture and prepares solutions as directed by work order. Documents work in the work order packages as needed. Keeps accurate records as needed for solution manufacture and prepares solutions as directed by work order. Documents work in the work order packages as needed. Must proactively support shutdowns by creating punch-lists, ensuring spare parts are ordered/working with the maintenance team to support and organize maintenance shutdown activities. QualificationsMust-Have High School/GED required Experience with complex SVP solution formulation is required. A high working knowledge of HMI operation is preferred. Must be able to work with computerized drug weigh programs. Have some knowledge of chemistry, the metric system, scales, and the filtration process. Must be able to evaluate prepared solutions to confirm dissolution of all drug components. Must be able to confirm cleaned equipment meets the requirements of “visually clean”. Operators are required to wear personal protective equipment as indicated by area standard operating procedures. Must have the ability to recognize when processes, procedures, equipment, product, commodities, etc are out of specifications. Failure to exercise independent judgment may result in spoiled batches, lots, loads, commodities, up to and including a product re-inspection or recall. Improper use or monitoring of equipment may result in substantial downtime, equipment and material or product loss. Nice-to-Have Experience with supporting engineering teams and development of new processes preferred 2 years of Pharmaceutical Production Experience preferred, PHYSICAL/MENTAL REQUIREMENTS Must be able to read, interpret, and perform job duties as prescribed in the operating procedure. Must demonstrate experience and competence in following detailed instructions. Must be able to read and interpret equipment data and demonstrate ability to communicate work requirement and problems in a concise and accurate manner. Must be able to work in a controlled temperature environment wearing clean room attire. On occasion, steam, noise, chemical odors, and fumes may be present. Stand up to10 -12 hours per shift, sit for up to 5-6 hours per shift, regularly lift up to 50 pounds per activity 1 time per shift, walk, climb stairs, climb ladders/walk on catwalks, occasionally may lift over 50 pounds with assistance NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Schedule primarily day shift, 7 am to 7 pm. Weekend and/or Holiday hours may be required in order to meet business and/or customer needs. Work Location Assignment: On Premise The salary for this position ranges from $24.88 to $41.46 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company's policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - North Carolina - Rocky Mount location. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Manufacturing
    $24.9-41.5 hourly Auto-Apply 60d+ ago
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  • Sr Project Support Professional

    Pfizer 4.5company rating

    Pfizer job in Rocky Mount, NC

    Use Your Power for Purpose Whether you are involved in the support of projects for manufacturing processes or supporting critical site infrastructure, your role is crucial in ensuring that customers and patients receive the medicines they need, precisely when they need them. By collaborating with our forward-thinking engineering team, you will contribute to accelerating the delivery of medicines to the world. Your innovative ideas and proactive actions will help us push the boundaries of what's possible, ensuring that we meet the needs of those who rely on our products. What You Will Achieve The Senior Project Support Professional role will support all phases of assigned capital projects and systems at the Pfizer Rocky Mount, NC site. This will include updating and managing AutoCAD files, preparing project scopes, budgets and schedules, change controls, project approval routing, purchase orders, bid events, contractor training, installation and qualification of equipment and systems, project closure, forecasting, and financial accounting. Provide technical support to manufacturing operations and other business units as required. Liaise with equipment subject matter experts. Your role will oversee and manage the operational aspects of ongoing engineering projects and serve as a conduit between engineering and support teams. In your role, you will review the status of projects and budgets; manage schedules and prepare status reports. You will assess project issues and develop resolutions to meet productivity, quality and client-satisfaction goals and objectives. In this role, you will: Capital Project Authorizations Assist with the development and routing of electronic capital funding requests (CPA's). Facilitate requests for release of Contingency funding and Project Change Notices. Ensure project requests are correctly routed and prioritized. Procurement Initiate capital purchase orders, change orders, and closures. Expedite PO's and purchases as required. Initiate work orders for assigned projects. Complete Bid Exception requests. Work closely with all suppliers, vendors, and Procurement on all capital purchases. Expedite purchases and bid events as required. Initiate and maintain vendor qualification documentation. Maintain purchase order tracking logs and issue accrual guidance as needed. Provide follow-up with suppliers to ensure timely deliveries and address any possible delays that may impact project schedule. Resolve all PO discrepancies, between financial systems and with other enabling groups including GFSS, finance, procurement, and EAMS. Work with suppliers to ensure timely submittal and approval of invoices and milestone payments to meet cash flow objectives including monthly accruals. Resolve all invoicing discrepancies and payment issues. Change Control Author and assign actions to all support groups on assigned projects. Track impact assessments and action items to ensure project stays on schedule. Ensure qualification documentation and activities are completed appropriately. Project Reports Maintain cost spreadsheets on assigned projects. Assist Project team in an accurate assessment of a project's status and spending forecasts, project fund dates, project closure dates, and other critical project information in CPM database. Ensure alignment between SAP project accounting and our capital portfolio manager database. Support and manage cost controls for the broader team including area, driver, project manager, and other key site forecasts. Support, develop, and create spreadsheets and presentations to support periodic reporting and repetitive meetings. Ensure complete, accurate and timely reporting of a project's status and any issues to the appropriate levels in the department. Develop meeting agendas and presentations to support Engineering leadership. Finance Functions Facilitate project closure for capital projects. This includes PO/Invoice reconciliations, drawing reconciliation, Cost accounts balanced, creation of asset capitalization form, GCR reconciliation, NOEM preparation, asset creation, preventive maintenance and calibration task creation, and spare parts setups. Asset under construction (AUC) aging review and capitalization. Support corporate procedures on capital and expense guidelines, corporate procurement guidelines, bid exceptions and other project management guidelines and practices. Maintain Pfizer confidentiality on bids, finances, and all other information. Understand and facilitate taxation or no taxation on purchases per guidelines. Engineering Business Process Systems Administer Project Engineering's TEAMS sites Maintain all forms for Project Engineering. Manage Contractor Training and Get Access system for all projects. Support, execute, and handle routing processes for CPA's, Project Initiation Forms, Project Engineer assignments, Single Purchase Capital Requests (SPCR's), Project Change Notices, NOEM's, Lead low to medium complexity projects, effectively managing time and resources Work independently on assignments, seek guidance on complex problems, and review your own and others' work Here Is What You Need (Minimum Requirements) Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with more than 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience. Ability to track performance against approved plans Excellent oral and written communication skills, including the ability to deliver presentations Proficiency in user-level computer knowledge for completing documentation and tools such as Excel, Word, Outlook, Teams, and Project management tools Basic understanding of Current Good Manufacturing Practices and facility/equipment change control requirements Strong analytical and problem-solving skills. Good people management, direct or indirect management, skills. Ability to adapt to changing priorities and work effectively under pressure Strong interpersonal & communications skills and the ability to build relationships across the organization Bonus Points If You Have (Preferred Requirements) Technical degree in engineering or equivalent Proven ability to manage multiple projects simultaneously Experience with Life Cycle Asset Management PMP (project management professional) or similar project management certification. Strong managerial or supervisory experience in Engineering or Manufacturing. PMP (project management professional) or similar project management certification. Experience with project cost control management and forecasting. 6 Sigma Green Belt or Black Belt certified Background in manufacturing, automation, and utility support systems CMRP (certified maintenance and reliability professional) or CEM (certified energy manager) Other Job Details: Work Location Assignment: On Premise Last day to apply: 12/30/2025 Work Location Assignment: On Premise The annual base salary for this position ranges from $82 700,00 to $133 900,00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10,0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Engineering
    $82.7k-133.9k yearly Auto-Apply 7d ago
  • Field Service Technician (Entry Level) - Greenville, NC

    Procter & Gamble 4.8company rating

    Greenville, NC job

    (Internal Job Title - Sr. Field Service Technician) P&G Professional is the commercial division of Procter & Gamble focused on improving the lives of our consumers away from home. We provide the hospitality, foodservice, and long-term care industries chemical programs and solutions that keep their facilities clean and safe. The Senior Field Service Technician (FST) is a field based position working independently to install, troubleshoot, repair, and maintain our chemical dispensing equipment as well as other equipment used in commercial foodservice or laundry operations. The goal is to deliver exceptional service (not sales) in a way that delivers customer retention and superior customer service. This is a full-time position with Procter & Gamble that includes a competitive healthcare plan and retirement benefits. P&G Professional is expanding rapidly across North America and this position offers the opportunity to join a great company that can offer significant career opportunities as we continue to grow. Job Qualifications The ideal candidate would have a great work ethic and a willingness to learn new skills with provided training. This candidate would have a basic understanding in electronics, plumbing, maintenance or mechanical systems with the ability to troubleshoot with root cause analysis. Moderate working knowledge of appropriate tools, data, implements and service needs. Proficient in laptop and cell phone technology to include but not limited to Salesforce, Microsoft Word and Excel. Candidate must have a valid driver's license. Occasional overnight travel is required. Essential Job Functions * Work Schedule is a 5 day work week / 8 hours per day but may include: 12-hour shifts, occasional weekends, and night shifts * Lift, lower and carry objects up to 50 lbs. * Push and pull objects up to 50 lbs. * Climb a vertical ladder. Ability to go up and down * Climb up and down stairs * Stand, sit, and/or walk for long periods of time, twist, bend at the knees , stoop, kneel, squat, crawl, and reach for purposes of installing and maintaining equipment. Surface: Concrete, asphalt (uneven surfaces). * Operate a computer keyboard to input and access data, and phone * The ability to give and discern the various visual and audible alarms and signals for equipment startup, evacuation, and fires * Candidate must be able to operate a motor vehicle, and spend approximately 30% of the day in the car traveling from accounts safely in city, rural and expressway conditions * Must have a valid driver's license. * The ability to work in extreme temperatures both hot and cold, generally in warehouse conditions including wide variances in temperature, dust and dirt. Other Requirements * Candidate must live in specified city * On-call Coverage which may include occasional weekends, holidays, and night shifts Compensation for roles at P&G varies depending on a wide array of non-discriminatory factors including but not limited to the specific office location, role, degree/credentials, relevant skill set, and level of relevant experience. At P&G compensation decisions are dependent on the facts and circumstances of each case. Total rewards at P&G include salary + bonus (if applicable) + benefits. Your recruiter may be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the hiring process. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, disability status, age, sexual orientation, gender identity and expression, marital status, citizenship, HIV/AIDS status or any other legally protected factor. Immigration Sponsorship is not available for this role. For more information regarding who is eligible for hire at P&G along with other work authorization FAQ's, please click HERE. Procter & Gamble participates in e-verify as required by law. Qualified individuals will not be disadvantaged based on being unemployed. Job Schedule Full time Job Number R000140313 Job Segmentation Plant Technicians Starting Pay / Salary Range $24.18 / hour
    $24.2 hourly 43d ago
  • Director, Parenteral Sterility Assurance

    Eli Lilly and Company 4.6company rating

    Raleigh, NC job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: * Assess differences in current sterility assurance programs across the sites and drive harmonization * Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. * Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. * Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. * Building, maintaining, and growing capability across the organization in the sterility assurance space * Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. * Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. * Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. * Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. * Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. * Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: * BS Degree required. * MS/PhD in a biological science preferred. * 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. * 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. * Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) * Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities * Strong written and oral communication skills * Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance * Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space * Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance * Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. * Strong capability to influence personnel and management across the organization * Close interaction with quality to enable internal audits that identify risks * Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: * Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $133,500 - $246,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $133.5k-220k yearly Auto-Apply 60d+ ago
  • QC Supervisor - Weekend Shift

    Pfizer 4.5company rating

    Pfizer job in Rocky Mount, NC

    Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. You will play a crucial role in improving patients' lives by ensuring the highest standards of quality and safety in our products. Your leadership will be instrumental in driving innovation and excellence, ultimately making a global impact on patient health. What You Will Achieve Under the general guidance and functional direction of the CQ Laboratory Manager, the QC Supervisor is responsible for supervision of analysts performing chemical testing in a safe, compliant and efficient manner of raw materials, in process, and finished product samples. This position will evaluate analytical data to determine compliance with established specifications. The QC Supervisor is expected to resolve daily analytical and quality problems, generally without any additional high level technical assistance other than the chemical quality manager/director. In this role, you will: Consistently adheres to company, site, and laboratory safety rules and immediately raises any safety issues with supervision as soon as they are identified. Follows procedures at all times, adopting cGMP, cGDP practices. Supervision of QC Chem change control Schedule work sequences for documentation personnel and track progress of work sequences and provide feedback and coaching as required Participate in daily and weekly planning discussions with team offering suggestions to improve efficiency and schedule adherence. Resolve daily problems, generally without any additional high level technical assistance other than the chemical quality manager. Review and provide feedback on SOP's, Investigations, and Reports as needed in the absence of Management. Spearhead special projects such as Continuous Improvement initiatives or process flow improvements Act as Liaison between lab analyst, data review, change control and investigations were appropriate Demonstrated strong technical and leadership skills Ability to serve as primary CQ representative on multidisciplinary project teams Act as Department representative for Internal and External Business tours and Audits Here Is What You Need (Minimum Requirements) Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with more than 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience. Strong written and verbal communication skills. High level of organizational skills and independence. Strong judgment and decision making ability. Must be familiar with cGMP and cGLP for a pharmaceutical industry. PHYSICAL/MENTAL REQUIREMENTS Stand up for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective clothing (lab coat, safety glasses, gloves, face shield/goggles, apron), repetitive use of upper extremities. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Shift: Weekends, Friday - Monday, 10 hour first shift There are no out of the ordinary travel or shift requirements associated with the position. Individual will be expected to work nonstandard schedule as needed to support the business objectives Last day to apply: January 30, 2026 Work Location Assignment: On Premise The annual base salary for this position ranges from $82,700.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Quality Assurance and Control
    $82.7k-133.9k yearly Auto-Apply 8d ago
  • Team Lead, ECA and Commodity Prep - Day Shift

    Pfizer 4.5company rating

    Pfizer job in Rocky Mount, NC

    Use Your Power for Purpose Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need. What You Will Achieve ROLE SUMMARY The Team Lead, Operations Area plays a pivotal role in ensuring the seamless functioning of the production floor. You will lead a front-line team in the Equipment and Commodity Preparation area within the Plant Supply & Logistics Focus Factory, ensuring that production schedules are met while adhering to approved budgets and labor standards. You will be responsible for overseeing the workflow, managing the team, and ensuring that all processes are carried out compliantly, safely, efficiently and effectively. This involves coordinating with various departments, monitoring performance metrics, and implementing strategies to improve productivity. You will also ensure compliance with site SOPs and regulations, maintains seamless operation, and drives continuous improvement in the department, while maintaining a safe environment. Your leadership will provide direction to production colleagues, manage performance, and foster colleague development through timely feedback and appraisals. You will contribute to the overall success of the production process, ultimately ensuring that patients receive high-quality products in a timely manner. You will employ a combination of communication, and problem-solving skills. You will lead by example, providing guidance and support to their team members while fostering a collaborative work environment. Effective communication is key, as you must deliver information between different departments to ensure that everyone is aligned with the area's objectives. You will identify and resolve issues that may arise, using your analytical skills to develop solutions that enhance efficiency and reduce costs. By leveraging these skills, you will contribute significantly to the overall success and growth of the organization. This role offers the opportunity to lead, innovate, and make a significant impact on the production process. This position will report to the Manager, ECA/ Commodity Preparation a Focus Factory. It is your dedication and hard work that will make it possible for Pfizer's customers and patients to receive the medicines they need, when they need them. ROLE RESPONSIBILITIES Front line leadership of shop floor for Formulations and/or Equipment and Commodity Preparation within the Plant Supply & Logistics Focus Factory Ensure that production schedules are achieved, operating within approved budgets and within labor and material standards at the lowest possible cost, meeting all necessary cGMP, Quality and Safety requirements. Assist the Manager with projects, reports, and other assigned duties. Provide management direction production colleagues within the associated areas. As a supervisor, you will assure on-time training and evaluate/manage colleague performance to maximize the efficiency of area personnel. Actively engage in colleague development, including timely performance feedback/appraisals as well as through other aspects of the performance management process (i.e. 1:1s, IDPs). Evaluate the production process for efficiencies and make improvement recommendations to area management. Schedules staffing, optimizing labor available to meet required product demands of customers within budgeted guidelines, communicating with and recommending actions to leadership as needed. Meet production goals as assigned. Collaborate cross-functionally with Quality, Maintenance, Warehouse and other production personnel to ensure information is properly shared and production remains on schedule. Identify process improvements and supports continuous improvement initiatives related to compliance, safety and production to minimize risk, ensure product quality and reduce waste through the application of OpEx and IMEx principles. Review batch records, supports release of production lots and ensures product meets quality and quantity standards. Evaluate any potential delays in the production schedule and make recommendations to area management to resolve the issues. Ensure completeness of all documentation associated with the process. Anticipates and reacts to shortages of material, equipment, personnel, and space to meet schedule and maintain inventory. Assure adherence to Good Manufacturing Practices and company regulations. Determines manufacturing methods, procedures, and tooling requirements. Designs tools and plans production sequences. Performs detailed scheduling of manufacturing work in process, shop loading and physical control of in-process inventories. Expedites workflow and coordinates changes in schedules. Assembles component parts, sub-assemblies or completed units. Includes electronic, electro-mechanical, mechanical, structural products, instrument, and plastic parts assembly. Changes the characteristics of material by chemical means or performs the following functions working with material: heating/cooling, bonding, laminating, plating, etching, engraving, production painting, silk screening, molding plastics, glass working, and chemical processing. Level of Technical Scope include SAP, PDOCS, EAMS, PLOGS, CLAN, EQMS, IPL, RDOCS. Influence and drive day to day operational decisions Maintain consistent cross training of colleagues increasing Technical Skills to meet the level of Job Scope. Responsible for continuous improvement including operational systems, processes, and policies. Implement and maintain integrated manufacturing excellence (IMEx) lean manufacturing system Incorporate Operational Excellence elements into the organization through visual management, production performance and metrics, six sigma and lean principles Ensures that all manufacturing methods and practices are consistent with industry and Pfizer standards. Engages with the sites quality assurance, quality control, validation, engineering, technology services, supply chain and regulatory departments to ensure the sites manufacturing needs, regulatory standards and company policies are met. Here Is What You Need (Minimum Requirements) BASIC QUALIFICATIONS Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience Experience working in a regulated environment PREFERRED QUALIFICATIONS Experience in manufacturing operations. Strong problem-solving and analytical abilities, with a strong attention to details. Proven leadership and mentorship skills with ability to motivate and inspire team members towards achieving common goals. PHYSICAL/MENTAL REQUIREMENTS Physical Requirements: Ability to perform tasks such as lifting, sitting, standing, walking, and bending. Capability to perform mathematical calculations and complex data analysis Mental Requirements: Strong analytical and problem-solving skills to address disposition and supply chain issues. Attention to detail with a high level of accuracy in managing disposition sequences and timelines. Ability to work in a fast-paced, dynamic environment managing multiple priorities NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS May involve working in shifts to ensure continuous production operations, including early morning, late evening, or overnight shifts. May be required to work on weekends and holidays to meet production deadlines or address urgent issues. Required to be on-call to handle emergencies or critical situations outside of regular working hours. During peak production periods or tight deadlines may require working extended hours to ensure tasks are completed on time Work Location Assignment: On Premise The annual base salary for this position ranges from $82 700,00 to $133 900,00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10,0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Manufacturing
    $82.7k-133.9k yearly Auto-Apply 8d ago
  • Cardiovascular Health and Science Professional (HSP)

    Pfizer 4.5company rating

    Pfizer job in Raleigh, NC

    **Cardiovascular Health and Science Professional (HSP) - Wilmington, NC** All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues can grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and can impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. Pfizer has a deep heritage and leadership in cardiovascular disease, and we are committed to providing breakthroughs that change patients' lives. An integral part of Internal Medicine, the Cardiology (CARD) Team's mission is to promote a breakthrough therapy for patients suffering from NVAF or VTE. The CARD Health & Science Professional (HSP) is responsible for increasing territory sales and relationship development with assigned customers and accounts by engaging in product promotion and determining the best strategies to manage their business. A CARD HSP should possess customer, market, and business acumen, analytical skills, and strong product and disease state knowledge; demonstrate ability to drive sales, promotional and strategic business development and management skills, and in-depth customer engagement expertise both in-person and virtually; demonstrate outstanding communication and teamwork skills; be adept in the operation of digital and virtual tools; and be effective at working remotely in collaboration with cross-functional internal teams to address customer needs and compliantly deliver on Pfizer business objectives. **ROLE RESPONSIBILITIES** + Drives sales in assigned territory. + Engages with customers both face to face and virtually. + Develops and implements effective business and territory call plans; effectively identifies and implements live/virtual engagement strategies with customer to maximize overall effectiveness and impact. + Effectively builds rapport and relationships with customers in both live and virtual environments; uses judgment to maintain customer engagement by successfully utilizing existing and ever-changing digital tools effectively for successful customer engagement. + Understands and leverages internal reports and analytics to assist with identifying, developing, and implementing strategic business opportunities. + Compliantly leverages product and disease state knowledge to appropriately educate providers on unbranded and branded product value proposition for relevant patient populations and effectively and strategically utilizes approved clinically oriented disease state information and patient resources, as applicable. + Demonstrates strong teamwork capabilities to collaborate effectively and compliantly across the organization to address customer inquiries and advance Pfizer objectives. + Completes all administrative expectations on time and compliantly. **BASIC QUALIFICATIONS** + Bachelor's Degree. + Minimum 2 years of experience in one or more of the following; OR an associate's degree with 6+ years of experience; OR high school diploma (or equivalent) with 8+ years of **relevant** experience.- Professional Sales or Promotional Activity.- Small Business Owner or other Entrepreneurial experience, Marketing, Customer Service and/or Account Management.- Relevant Healthcare/Scientific roles (e.g., RN, Pharmacist, PT, OT, etc.).- Educator (e.g., Teacher, Principal).- Full Time Military experience. + Must live within 25 miles of the border of the territory. + Valid US driver's license and driving record in compliance with company standards. Any DUI/DWI or other impaired driving citation within the past 7 years will disqualify you from being hired. **PREFERRED QUALIFICATIONS** + 1 year of pharmaceutical, biotech, medical sales and/or medical related marketing. + Strong track record of sales or marketing success, strong territory management skills, outstanding communications skills, as well as demonstrated teamwork, leadership ability and accountability. + Experience with applicable disease states, therapeutic area, and products. + Knowledge of posted territory customers and markets (prescribers/HCPs/institutions/organizations). + Reside within the territory boundaries. **NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS** + Ability to travel to all accounts/office locations within territory. + Depending on size of territory and business need, candidates may be required to stay overnight as necessary. **OTHER JOB DETAILS** + Last Date to Apply: January 26, 2026. + Geography includes: Wilmington, New Bern, Jacksonville, and Kinston in North Carolina. + Work Location Assignment: Remote - Field Based. The annual base salary for this position ranges from $85,000 - $186,700. **During initial new hire sales training, you will be classified as a salary non-exempt employee which entitles you to overtime pay. Upon your training certification, you will become an overtime exempt employee.** In addition, this position offers an additional quarterly Sales Incentive bonus. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits| (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. **Sunshine Act** Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. **EEO & Employment Eligibility** Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Sales
    $27k-38k yearly est. 9d ago
  • Manufacturing Execution System (MES) -Lead

    J&J Family of Companies 4.7company rating

    Wilson, NC job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Supply Chain Engineering **Job Sub** **Function:** Automation Engineering **Job Category:** People Leader **All Job Posting Locations:** Wilson, North Carolina, United States of America **Job Description:** Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine . J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. The GET (Global Engineering & Technology) organization operates as one integrated team in the delivery of Engineering, Maintenance and Execution Systems solutions. We operate in a standard, coordinated and consistent manner in support of the current and future requirements of our Manufacturing and Manufacturing Science and Technology (MSAT) and in partnership with key internal/external network. Apply today for this great opportunity located in Wilson, NC! The MES Lead drives the design and configuration activities of site's Kroeber PAS-X MES, including MBR design, vendor management, production, validation and development systems, system standards, and interfaces to DCS & IT systems. The new facility and the production process are envisioned to be highly automated with data being shared across multiple platforms to support production, from raw material receipt to disposition of the produced drug substance. Data generated at each stage of production will be shared across business information and control systems, including the multivariate analysis to support predicative models for process control and disposition support. **Key Responsibilities:** + lead the design, deployment and continues improvement of site MES + Oversee technical team of vendors and contractors to ensure requirements are implemented and tested correctly + Collaborate cross-functionally with Manufacturing, Quality, Engineering, and IT to identify and implement digital solutions that enhance productivity and data accuracy. + Lead the planning, execution, and completion of MES application configuration activities like MBR, item management, equipment management, label management from start to finish. This includes defining project scope, creating technical designs, and managing project execution. + Work hand on hard with IT in seamless integration of the MES with other enterprise and shop floor systems, such as ERP, SCADA, and LIMS, to enable real-time data flow. + Provide in-depth technical support and troubleshooting for MES-related issues, including troubleshooting configuration errors, and integration challenges with DeltaV. Develop and maintain technical documentation. + Ensure that site and global standards are met. + Lead risk assessments. + Support GMP audits. **Qualifications** **Education:** + Bachelor's degree in engineering, IT, Science or related field; required **Experience and Skills:** **Required:** + A minimum of 8 years of experience in a manufacturing environment, biopharmaceutical or pharmaceutical industry, or an equivalent combination of education and experience + In-depth knowledge of MES platforms (e.g., Werum PAS-X) and interfaces to IT and DCS. + Proficiency in MES software platforms, with strong programming skills in areas like .NET, SQL, PL/SQL, and Java. Expertise with OPC servers and clients for data exchange is also valuable. + Strong analytical and problem-solving skills to handle complex technical challenges and provide effective solutions. + Proven ability to lead technical teams, manage projects, and mentor junior engineers. + Excellent communication skills to effectively present technical information to both technical and non-technical audiences, and to gather requirements from clients. + Knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11. + Proven experience within a pharmaceutical or GMP regulated manufacturing environment + Experience in supervision/management of people and resources. + Process knowledge for Upstream, Downstream and Bio Processing Support functions. **Preferred:** + Good appreciation of Industry 4.0/IoT + Experience in integrating MES system with DeltaV PAS & OSI PI data historian + Good understanding of batch release reports and release by exception **Other:** + _Ability to travel up to 10% of the time, domestic and internationally_ For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ******************* .] Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. **Required Skills:** Computer System Validation (CSV) **Preferred Skills:**
    $70k-90k yearly est. 60d+ ago
  • Sr. Oncology Sales Representative - North Orange County, CA

    Merck 4.6company rating

    Raleigh, NC job

    Our Sales team support our customers by providing clinical information about products, educational information, clinical training programs and resources. We support healthcare providers and healthcare systems meet the goals of the patients in their communities. Our Company's Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of dauntless, forward-thinking individuals achieves this through an unwavering commitment to supporting accessibility to medicine, providing new therapeutic procedures, and collaborating with governments and payers to ensure that people who need medicines have access to them. At our company, our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe. As we continue to grow and define the Oncology market of the future, we are looking for dynamic, entrepreneurial individuals who thrive in a team environment and are driven to succeed. The Oncology Sales Specialist is a key member of our customer facing organization and is responsible for partnering with customers to address identified needs, educating key stakeholders about our leading immunotherapy compound, and communicating our vision to the larger Oncology community. + This is a field-based sales position that will cover the **North Orange County, California** + The selected candidate must reside within the territory. + Overnight travel may be required about 25% of the time. + Travel (%) varies based on candidate's location within the geography. **General Responsibilities:** + Demonstrate in-depth knowledge of how to create a compelling and logical rationale for the value of products and how to contrast, compare, and position our company brand(s) versus competition using appropriate resources in informed discussions about products with HCP customers - knowing when/how to seek and provide additional information + Act as primary point of contact for customer. Meet with key customers/personnel to understand practice structure, business model, and key influencers. + Possess knowledge of cancer staging and possible treatment options and dosing schedules associated with different tumors/diseases, with comprehensive understanding of the impact of those options on the patient. Must understand impact and use of clinical trials in multiple tumor types/therapies, both in impact on promoted products and in practice behavior of the account. + Ability to analyze and identify trends in a complex buying environment. This includes the multiple channels of drug distribution, Oncology GPO's, wholesalers and specialty pharmacies. Review and evaluate patterns for products purchased and prescribed, outpatient vs in-patient infusion, as part of hospital contract, etc. + Demonstrate ability to understand complex account interdependencies in order to develop both short- and long-term account plans in conjunction with a wide array of stakeholders, proactively working with the account team and supervisor (known as the Customer Team Leader) to effectively execute the account plan. Share learnings and best-practices from one customer to help other customers meet their needs. + Influence beyond their specific geography or product area demonstrate advanced ability to ask strategic, insightful questions to obtain information on customer needs from all stakeholders in oncology accounts, using the insights to position our company Oncology brands and collaborate with customers on a customized strategy. + Collaborate and communicate effectively with extended "in-scope" customer team to ensure a consistent customer experience across our company's divisions and functional areas; ensure integration with the Key Account Manager, Nurse Educator, Field Reimbursement Associate, Medicare Account Executive, and other key stakeholders to share key customer learnings and support customer needs. **Position Qualifications** **:** **Minimum Requirements:** + Bachelor's degree with 6-8 years Sales experience OR a minimum of high school diploma with at least 10 years of equivalent experience + Equivalent experience can be: Professional sales experience, work experience in the healthcare/scientific field (including pharmaceutical, biotech, or medical devices) that is not sales related, professional marketing experience, or military experience + 2+ years of oncology field sales experience + Valid driver's license and ability to drive a motor vehicle + Travel the amount of time the role requires **Preferred Experience and Skills:** + Documented history of strong performance in a sales / marketing or oncology clinical role + Clinical oncology experience across multiple solid tumors (Women's cancer - Breast, Ovarian, and Cervical) + Candidates with 0 - 2 years of oncology field sales experience will be hired at the S2 Oncology Sales Representative level. + Candidates with 2+ years of oncology field sales experience will be hired at the S3 Oncology Sales Specialist level. oncosales **Required Skills:** Account Management, Account Management, Account Planning, Adaptability, Biodesign, Biopharmaceutical Industry, Cancer Diagnosis, Clinical Experience, Customer-Focused, Customer Handling, Customer Relationship Management (CRM), Customer Service, Healthcare Sales, Interpersonal Relationships, IS Audit, Lead Generation, Lead Generation Management, Market Analysis, Medical Devices, Oncology Nursing, Oncology Sales, Pharmaceutical Management, Pharmacology, Product Knowledge, Proven Commitment {+ 5 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $156,900.00 - $247,000.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 25% **Flexible Work Arrangements:** Remote **Shift:** Not Indicated **Valid Driving License:** Yes **Hazardous Material(s):** N/A **Job Posting End Date:** 01/22/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381203
    $156.9k-247k yearly 7d ago
  • Maintenance Technician IV

    Pfizer 4.5company rating

    Pfizer job in Rocky Mount, NC

    Use Your Power for Purpose Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring customers and patients receive the medicines they require when they need them. By collaborating with our forward-thinking engineering team, you'll contribute to delivering medicines to the world more swiftly by envisioning new possibilities and taking decisive action. What You Will Achieve Take responsibility for individual contributions to team deliverables, representing the work group within department teams, and fostering a positive team environment. Manage personal time and professional development, prioritize workflow, and assist less-experienced colleagues in prioritizing their tasks. Complete various assignments based on established procedures, identify process improvements, troubleshoot issues, and provide direction and training to team members. Share knowledge within and across multiple work groups, and proactively resolve non-routine problems by making informed decisions. Work under general supervision, independently handle recurring assignments, and refer new or unusual problems to the supervisor. Ensure non-standard work is reviewed for sound technical judgment, and hold oneself accountable to Pfizer standards, guidelines, and values, while training others. Adhere to safety procedures, job safety analysis (JSA), and safe work permits, ensuring compliance with plant safety programs. Coordinate maintenance and project activities with production personnel to minimize downtime, and understand general shop safety practices. Ensure utility activities comply with SOPs, cGMP, and other regulatory practices, and read and follow equipment schematics, blueprints, and engineering drawings. Perform calibration of production and facility equipment, use electrical testing equipment safely, analyze and resolve equipment problems, instruct other technicians, and design and install electrical sensors or control systems. Here Is What You Need (Minimum Requirements) High School Diploma or GED with 4+ years of experience Certification in the assigned area if applicable Course work or equivalent experience in electromechanical technology Solid understanding of basic mathematics and general trades such as construction, electrical, and machine shop Ability to perform a range of maintenance tasks involving mechanical, electrical, pneumatic, hydraulic, and automated systems Proficiency in computer skills Good written and verbal English communication skills Bonus Points If You Have (Preferred Requirements) Bachelor's Degree Pharmaceutical and/or Bio-Pharmaceutical experience Knowledge of Current Good Manufacturing Practices (cGMP) operations Strong problem-solving skills Ability to work collaboratively in a team environment Excellent organizational skills Strong attention to detail Familiarity and basic understanding of common AI tools and a curiosity for learning how they can be used to enhance productivity PHYSICAL/MENTAL REQUIREMENTS Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS 12 hours, rotating Tues, Wed -Sat, Sun, Mon - Thu, Friday shift. Other Job Details: Work Location Assignment: On Premise Last day to apply: January 27th The salary for this position ranges from $32,01 to $53,35 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company's policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - North Carolina - Rocky Mount location. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Engineering
    $32 hourly Auto-Apply 3d ago
  • Director/Senior Director, Global Process Owner - Sterility Assurance QMS

    Eli Lilly and Company 4.6company rating

    Raleigh, NC job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Company Overview: At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. Position Brand Description: The Director/Senior Director, Global Process Owner for Sterility Assurance, as a leader within the Technical Service, Manufacturing Sciences, Sterility Assurance team, will establish and maintain the global quality system procedural requirements for a Level 2 Process related to Aseptic Processing controls inclusive of Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, and Aseptic Training. They will provide strategic oversight and expertise for global Aseptic Processing Programs, including Quality Management System Sterility Assurance standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will lead an Aseptic Processing Program Community of Practice, including Global Process Leads and Area Process Owners. They will lead key global projects and priorities within the Sterility Assurance Level 1 Program. The Global Process Owner will consult with Lilly manufacturing facilities, Global and Site Quality and other functions to educate on the Sterility Assurance program requirements, and proactively ensure compliance of the Lilly Sterility Assurance program with various country agency standards, industry trends and scientific principles. Key Objectives/Deliverables The Director/Senior Director, Global Process Owner for Sterility Assurance Level 2 Processes is responsible to: * Establish and maintain the global quality system for Aseptic Processing Programs to drive standardization globally. * Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations. * Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset. * Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement. * Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics. * Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance. * Monitor performance metrics, report and provide insights to inform decision making to drive further improvements. * Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools. * Actively collaborate with enterprise-wide teams on standardized global business processes. * As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed. * Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Aseptic Processing requirements inclusive of Aseptic Process Simulations, Aseptic Technique and Barrier system (e.g. Isolators/RABs) management. * Provide overall guidance and leadership as related to Aseptic Process Simulation Program Design and Implementation, Aseptic Controls and Practices including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique Basic Requirements: * 10+ years' experience in the pharmaceutical industry in roles across commercial manufacturing and or quality in a manufacturing, validation, and/or Quality roles supporting aseptic product manufacturing * 7+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment. * Bachelor's degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field. * Candidate will have previous experience implementing and leading global Sterility Assurance programs which can include Aseptic Training, Aseptic Process Simulations, and Isolator Controls and Management. * Strong technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, contamination control, Annex 1 interpretation) * Strong written and oral communication skills * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals * Approximately 25% travel Additional Preferences: * Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control. * Experience leading a major multi-site or global functions improvement initiative. * Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities. * Proficiency in addressing operational challenges through structured approaches and innovative solutions. * Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data. * Demonstrated change agility in anticipating and leading others through change and ambiguity. * Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats. * Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity. * Demonstrated influential leadership expertise and experience engaging with senior-level functional leads. * Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results. * Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks. * Demonstrated people management experience. * Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. * Experience leading a major multisite improvement initiative or driving multisite standardization. * Prior demonstrated experience managing aseptic processing programs including global procedural requirements and training. * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance Education Requirements: BS/MS in a biological science (or equivalent work experience) or engineering discipline (Microbiology-preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.), preferably Microbiology. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $264,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $151.5k-264k yearly Auto-Apply 60d+ ago
  • Senior Medical Science Liaison- Autoantibody Pipeline-South

    Johnson & Johnson 4.7company rating

    Raleigh, NC job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Medical Affairs Group Job Sub Function: Medical Science Liaison Job Category: Scientific/Technology All Job Posting Locations: Nashville, Tennessee, United States, Raleigh, North Carolina, United States Job Description: Johnson & Johnson Innovative Medicine is searching for the best talent for a Senior Medical Science Liaison- Autoantibody Pipeline for the South region. This is a field-based position located in the South region, the preferred location is the Raleigh, NC or Nashville, TN area. The territory covers Louisiana, Arkansas, Mississippi, Kentucky, Tennessee, North Carolina, South Carolina, and Virginia. About Immunology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine. The Senior Medical Science Liaison (Sr. MSL) is responsible for providing fair balanced, objective, scientific information and education to opinion leaders (OLs), health care professionals, and to internal partners as required by scientific and business needs. The Sr. MSL is considered an established scientific and clinical knowledge lead on current and future J&J Innovative Medicine products per Therapeutic Area (TA) alignment. Sr. MSL is responsible for staying abreast of current scientific and treatment landscape trends in their therapeutic areas of interest. Sr. MSL provides research support for company and investigator-initiated research. The Sr MSL will function with high integrity and follow credo values. Sr. MSL is responsible for building external relationships with identified OLs and health care providers (MD, DO, PhD, PA, NP, RN, Pharm.D., bio coordinators) and developing and managing a geographical territory. These relationships and engagements can include both virtual & in-person, with a prioritization of in-person engagements when appropriate. The Sr. MSL is responsible for developing and maintaining a territory strategic plan, which includes educational activities with identified OLs, HCPs, institutions, and community practices. The Sr. MSL role is one that requires a level of competency and experience in the disease state. The Sr. MSL is expected to possess foundational competencies in the areas of Influence & Results Focused, Communication, Stakeholder Engagement, Product & Therapeutic Area Knowledge, and Data Insights & Dissemination. The Sr. MSL will be expected to rapidly identify and compliantly collaborate with field-based partners to ensure support of the Healthcare Providers, which will positively impact the patients that they care for. The Sr. MSL will continue to enhance their skills in agility, applying the competencies of Change Management, Time Management and Innovation. The Sr. MSL is responsible for conducting all activities in accordance with current regulatory and health care compliance guidelines. This is a field based clinical position which required travel, primarily throughout assigned geography, with infrequent meeting travel outside of assigned geography. Travel for this role is estimated at 70%. Responsibilities: Consistently demonstrate strategic territory planning and ability to build strong relationships within the territory. * Responsible for developing and maintaining a field strategic plan. * Responds in a timely manner to unsolicited scientific inquiries of HCPs/investigators/health care systems/academic medical centers and population health decision makers integrating scientific data including real world evidence into real life practice to meet customer needs. * Presents data and information in a manner appropriate to the audience and request. * Execute plans regarding reactive and proactive outreaches as approved via the legal/HCC exceptions process. * Integrates scientific data into real life practice to meet customer/audience needs, adapting interpersonal style to particular situations and people. * Anticipates the responses of various individuals and teams based on their vantage point and perspective. * Prioritize franchise customer-based initiatives and field responsibilities, while balancing administrative duties and project responsibilities. * Executes Research Initiatives: * Leverages knowledge of standards of care and Janssen company/investigator sponsored clinical trials and competitor landscape to facilitate external-internal research communication. * Engages with external investigators regarding unsolicited research inquiries and act as liaison to R&D, Medical Affairs and operations teams. * Provides clinical trial support to identify potential sites, resolve issues with enrolled sites, and participate in meetings as appropriate, including site initiation visits and investigator launch meetings. * Effectively leads at least one scientific or strategic Immunology project, exhibits strategic identification of educational gaps and elevates team acumen. Consistently demonstrates strong scientific acumen. * Actively participate in team calls, trainings, & journal clubs through scientific dialogue, understanding of current standard of care, and regularly sharing of scientific news. * Attends and provides leadership at scientific conferences to gather and understand new scientific information relevant to the company and the external scientific community. * Medical insights: Actively listens for, documents, and shares medical insights. Proactively synthesize data and medical insights for MSL team and other partners * Sets aside time for self-driven learnings on current scientific landscape. * Role includes representing and supporting JNJ at relevant scientific or other key stakeholder meetings including congresses, symposia, advisory boards and investigator meetings. * Role includes representing JNJ at speaking engagements at relevant scientific or other key stakeholder meetings. Continuous support Department Operations and Internal Partners: * Performs all administrative requirements in a timely, accurate and compliant manner (e.g. expense reports, documentation of activities) * Maintain focus and composure in uncertain circumstances with minimal direction. * Provide regional and local support to enhance sales training initiatives and improve competencies of field personnel in partnership with Sales Learning and Development * Communicates and collaborates with all field-based partners, and other Immunology MSL teams on a routine basis. * Demonstrate the ability to partner with others to lead or participate in large scale projects. * Maintains thorough understanding and competence in the following areas (regulatory and health care compliance guidelines; corporate policies on appropriate business conduct and ethical behavior; Medical Affairs SOPs and guidelines. Qualifications Required: A PharmD, PhD, MD, w/ 3+ years relevant hematology, immunology and/or auto/alloimmune disease experience Minimum 3 years MSL experience, and/or 2-3 years relevant work exp (clinical or research experience) Must be familiar with Microsoft Word, Excel, PowerPoint, and utilization of computers and remote technologies. Ability to travel up to 70 %. Preferred: Launch experience in rare disease is highly preferred. Significant experience giving presentations is highly preferred. Must be familiar with Microsoft Word, Excel, PowerPoint, and utilization of computers and remote technologies. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers and internal employees contact AskGS to be directed to your accommodation resource. #LI-Remote Required Skills: Preferred Skills: Analytics Dashboards, Clinical Research and Regulations, Clinical Trials, Consulting, Customer Centricity, Data-Driven Decision Making, Digital Culture, Digital Literacy, Medical Affairs, Medical Communications, Medical Compliance, Mentorship, Product Knowledge, Relationship Building, Research and Development, Strategic Thinking, Tactical Planning, Technical Credibility
    $90k-126k yearly est. Auto-Apply 10d ago
  • Sr. Principal Engineer, Utilities System Owner

    Johnson & Johnson 4.7company rating

    Wilson, NC job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Supply Chain Engineering Job Sub Function: Process Engineering Job Category: Scientific/Technology All Job Posting Locations: Wilson, North Carolina, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. The Make-to-Order (MTO) are responsible for supplying medicines to markets around the world. With Quality as our primary focus, our group strives to provide access and affordability through innovation and strong collaboration with our R&D and Commercial partners to deliver life changing solutions for patients in need. Support the deployment of the Make-to-Order (MTO) aspiration "to innovate to safely supply quality products and services competitively, faster, always". Responsible for providing advanced engineering design and start-up of GMP large molecule biologics manufacturing facilities, systems, and equipment; and providing engineering and technical/business support for new complex utility equipment and systems. Provide integrated equipment, utility, and facility engineering expertise with an operational and maintenance focus in support of manufacturing projects to support 'right first time' execution and start up. Management to drive innovative solutions in engineering support, and utility technology. Coordinate with internal stakeholders to ensure project alignment with technology standards and engineering specifications for GMP manufacturing. Provide technical mentoring, building high-performing utility or process engineering team. Key Responsibilities: * Extensive interaction with external partners (A&E, construction firms, equipment vendors) to develop, organize and execute project plans as SME and utilities systems owner. The incumbent should demonstrate the following: detail and goal oriented, teamwork, customer-focus, thorough understanding of GMPs and regulatory requirements. * Serve as Process Engineering Expert (Utilities, Process Systems) to develop business based technology solutions and provide integrated equipment, utility and facility engineering expertise with an operational and maintenance focus to support execution of strategic and key CAPEX manufacturing projects, driving 'right first time' start up and execution. * Explore and understand technology and manufacturing challenges and synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions. * Clear technical reporting, ability to explain technical tradeoffs to non-technical stakeholders, strong negotiation and conflict resolution. * High degree of collaboration with internal (manufacturing, quality, engineering) to develop standards and define project needs and priorities; as well as recruiting project team members. * The incumbent must also have a thorough understanding of business requirements, effective communication skills, leadership, and interdependent partnering, conflict and risk management. Qualifications : Education: * Minimum of a Bachelor's or equivalent University Degree; required * MS/MBA/Ph.D. PE Certificate preferred Experience and Skills: Required: * A minimum 12 years of utility experience in GMP MFG facilities. * Experience in green or brown field GMP MFG facility start-up including automation, utilities, facilities and operations. * Strong technical background in Utility, strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions Operational and financial fundamentals * Familiarity with ASME BPE codes, PLC/DCS automation controlled systems, P&ID and clean utilities including: WFI, clean steam, plant steam, process gases, chemicals. * The ability to lead and/or support multiple projects simultaneously * Defines technical or scientific direction of programs composed of multiple complex projects * Engineers new and modifies existing processes to ensure right first time process start up * Track record of successful program execution and team outcomes Preferred: * FPX certification and Six Sigma and/or Lean experience are a plus Other: * This position is full time on-site role based in Wilson, NC * This position may require up to 25% of domestic or international travel based on project business needs Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Good Manufacturing Practices (GMP) Preferred Skills: Agile Decision Making, Coaching, Consulting, Corrective and Preventive Action (CAPA), Crisis Management, Cross-Functional Collaboration, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Tactical Planning, Technical Credibility, Technical Research
    $100k-128k yearly est. Auto-Apply 9d ago
  • QA Specialist, C&Q/CSV

    J&J Family of Companies 4.7company rating

    Wilson, NC job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Quality **Job Sub** **Function:** Quality Assurance **Job Category:** Professional **All Job Posting Locations:** Wilson, North Carolina, United States of America **:** The purpose of this document is to outline the job description of the QA Specialist at Janssen Biotech, Inc in Wilson, North Carolina. The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance. **Essential Job Duties and Responsibilities** This position is responsible for ensuring compliance with regulatory requirements and company policies following current Good Manufacturing Practices, Johnson & Johnson Policies and internal procedures through the following duties and responsibilities: + Ensure the site validation program has been developed and maintained in compliance with all regulatory and corporate requirements and Master Plans. + Works with the applicable qualification teams representing Quality Assurance in the requirement, design review, construction, qualification and leveraging documentation strategies, cleaning development/validation and implementation of project. + Review and approve commissioning and qualification documentation, including URS (User Requirements Specifications), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports, SOP's, Work Instructions and any other technical document. + Review and approves validation protocols and reports (analytical, cleaning, process, etc.) + Provide quality oversight for C&Q/CSV and validation execution activities to ensure compliance with GMP, FDA, EMA, and other regulatory requirements. + Support the development and implementation of C&Q and validation plans, ensuring alignment with project timelines and deliverables. + Perform QA reviews of system impact assessments and categorization of equipment and utilities. + Ensure compliance with company quality standards, including SOPs, work instructions, and quality policies. + Act as the QA point of contact for deviations, CAPAs, and change controls related to C&Q and validation activities. + Provide recommendations for process improvements to enhance compliance and efficiency in C&Q and validation activities. + Reviews/approves Technology Transfer documents assuring they meet regulatory and J&J requirements. + Collaborate with cross-functional teams, including engineering, validation, and manufacturing, to address quality issues. **Additional Job Duties and Responsibilities:** + Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards. + Partners with other Departments to ensure that compliance systems are implemented in an efficient manner. + Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site. + Carries out tasks related to the administration of site nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS). + Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site. + Collaborate with cross-functional teams (Operations, Engineering & Maintenance, MSAT, QC, etc) to address quality issues. + Provides support to documentation review through evaluation and approval of documentation related to regulatory submissions, standard operating procedures (SOPs), and quality management systems to ensure accuracy and compliance as required. **Minimum Qualification** + Bachelor's degree in a scientific or engineering discipline is required. + Two to four (2-4) years of experience working within the biotherapeutic and/or pharmaceutical industry and knowledge in compliance of commissioning, qualification and validation of GMP processes and systems such as Utilities (water for injection, clean steam, process gases, HVAC, SIP/CIP), fridges, freezers, LAF, BSC units, autoclaves and isolators - as well as Process Equipment - Bioreactors, UF/DF, centrifuge, Chromatography systems. + Strong understanding of cGMP, FDA, EMA, ICH guidelines, and ISPE Baseline Guides. Hands-on experience with qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ) and cleaning/process validation. + Familiarity with ISPE guidelines, including GAMP 5, ASTM E2500, and validation lifecycle principles. + Strong understanding of risk-based approaches to commissioning and qualification/validation. + Proficiency in technical writing for validation and quality documents. + Strong communication and interpersonal skills for cross-functional collaboration. **Other requirements** + An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements. + Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams. + Proven ability to manage multiple priorities and work independently with minimal supervision. + Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements. + Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment. + Ability to build and nurture strong and positive relationships. + The ability to work in a team environment and interact with all levels of the organization. **Required Skills:** **Preferred Skills:** Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards **The anticipated base pay range for this position is :** $79,000.00 - $127,650.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). For additional general information on Company benefits, please go to: - ********************************************* This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year
    $79k-127.7k yearly 10d ago
  • Associate Area Manager or Area Manager - Eastern Region North Carolina - Johnson & Johnson MedTech, Heart Recovery

    Johnson & Johnson 4.7company rating

    Greenville, NC job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: MedTech Sales Job Sub Function: Clinical Sales - Surgeons (Commission) Job Category: Professional All Job Posting Locations: Fayetteville, North Carolina, United States, Greenville, North Carolina, United States, Wilmington, North Carolina, United States Job Description: We are searching for the best talent for an Associate Area or Area Manager to support clients and patients in the Eastern North Carolina which includes Wilmington, Greenville, Fayetteville and New Burn. About Cardiovascular Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech In this role as an Associate Area Manager, you and your clinical partner will be responsible for driving growth in the Boston East territory. You will attend cases and provide comprehensive guidance to physicians and staff on the use of our Impella product portfolio to drive positive outcomes. Your goal is to develop the market in a given territory to help recover hearts and save patients' lives. To be successful in your role you will need advanced knowledge in interventional cardiology, strong sales skills, and business savvy partnered with leadership and training skills that promote trust, respect and are backed by honor and integrity. Responsibilities: * Promote & sell Impella product line to established customers (physicians and Heart Teams including Interventional Cardiologists, Cardiac Surgeons, and Administrators). * Identify new customers (physicians and hospitals) and lead the efforts in activating new centers * Create account/territory business plans and build programs * Exceed sales for assigned territory * Initiate Impella development activities focused on increasing awareness in the market * Lead clinical teams whose expertise help drive Impella adoption in assigned territory Requirements: * A minimum of 3+ years of sales experience with 2+ years experience in cardiovascular medical device sales (Associate Area Manager role) * A minimum of 8+ years of sales experience with 5+ years experience in cardiovascular medical device sales (Area Manager role) * Proven track record of selling into a Cath Lab or surgical suite. * A proven track record in leading and motivating teams to successfully achieve quotas. * Strong knowledge of interventional cardiology. * Direct patient support experience. * Availability for emergent patient care. * Ability to drive patient outcomes. * Ability to travel up to 50% overnight. * Conduct duties and responsibilities in accordance with all state and federal laws and regulations governing the medical device industry. Preferred: * Bachelor's degree preferred or 7 years of cardiology industry experience * Experience selling within assigned geography preferred * Established relationships/network of Interventional Cardiologists and Cath Lab staff in the posted territory * Proven track record of technology adoption and market development Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource. At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time. Here's what you can expect: * Application review: We'll carefully review your CV to see how your skills and experience align with the role. * Interviews with the team: If you move forward, you'll meet with the hiring manager (and possibly others on the team) in one or two interview rounds, depending on the role. * Staying informed: We know waiting can be hard, so our recruitment team will keep you updated and make sure you know what to expect at each step. * Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these. At the end of the process, we'll also invite you to share feedback in a short survey - your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process! #RPONA Required Skills: Preferred Skills: Account Management, Analytical Reasoning, Business Behavior, Collaborating, Cultural Competence, Customer Analytics, Customer Centricity, Healthcare Trends, Learning Agility, Market Knowledge, Market Research, Oracle Customer Data Management (CDM), Problem Solving, Sales, Solutions Selling, Sustainable Procurement, Vendor Selection
    $82k-103k yearly est. Auto-Apply 9d ago
  • Institutional Spec Sales Consultant - Raleigh, NC

    Bayer Inc. 4.7company rating

    Raleigh, NC job

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. Institutional Spec Sales Consultant - Raleigh, NC Institutional Spec Sales Consultant - Raleigh, NC Institutional & Specialty Sales Consultant, Cardiology - Raleigh, NC PURPOSE The Institutional and Specialty Sales (ISS) team is being established to lead and drive launch activities for indications within the CVR portfolio. Responsibilities include driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for top priority Institutions (i.e., Hospitals and Health Systems), Cardiologists and Nephrologists both in the Institutional and Community settings. The ISS reports to the CVR Area General Manager (AGM) and will be an integral part of the Area Customer Squad, collaborating closely with Marketing, Market Access, Patient Services, and other internal partners, as appropriate, to drive the US Pharma outcomes. The span of coverage will be within the (Territory) metropolitan area. Travel up to 50% within the territory. The position is residence based. The candidate must be domiciled within the territory. KEY TASKS AND RESPONSIBILITIES The primary responsibilities of the Institutional & Specialty Sales Consultant are to: * Drive clinical demand, education and sales, building deep understanding of disease state, unmet needs and treatment options to effectively educate healthcare professionals and business stakeholders on the unique benefits of assigned products while balancing both efficacy and safety through detailing of approved clinical information for community-based healthcare professionals and health systems; * Build institutional advocacy to drive formulary/pathway/protocol adoption of cardiovascular-renal brand(s) to drive appropriate pull-through of approved products; * Develop, co-create with external and internal stakeholders and implement strategic business plans for identified top strategic Institutions with an in-depth understanding of local market dynamics that influence product sales; * Demonstrate expertise and knowledge of disease state, the marketplace, competitors, industry, and cross-functional activities/plans as well as possess analytical rigor to anticipate and identify business opportunities and challenges; * Build key business relationships within prioritized customers in the community and including key stakeholders at the Institutions (i.e., C and D Suite and Head of Pharmacy, Head of Quality), Cardiologists and Nephrologists; * Manage the P&T committee processes at the priority Institutions; * Collaborate with the cross functional and Area Customer Squads to develop and pull through the strategic partnerships with key customers; * Provide support to Area General Managers in strategic projects, as needed; * Leverage and embrace emerging technologies to enhance performance, while continuously striving to improve your proficiency; * Understand and comply with pharmaceutical industry guidelines and regulations and apply high ethical standard in day-to-day work. WHO YOU ARE Bayer seeks an incumbent who possesses the following: REQUIRED QUALIFICATIONS * Bachelor's degree or 10 years of relevant sales experience in competitive landscapes in lieu of a Bachelor's degree; * Deep expertise and understanding of the cardiovascular and/or renal therapeutic area(s); * Experience launching new products and product indications; * Excellent facilitation and verbal/written communication skills; * Ability to work under pressure and meet short deadlines; * Ability to comply with any customer credentialing and safety requirements (e.g., up-to-date vaccinations, trainings); * Valid driver's license and clean driving record required. PREFERRED QUALIFICATIONS * Advanced degree (preferably in the Life Sciences, Pharmacy or business-related field;) * 5 years of successful pharmaceutical/biotech/medical sales experience in competitive landscapes; * Experience selling in Institutions and clinic settings and navigating the P&T committee process; * Experience in establishing and pulling-through in-patient to out-patient protocols . Employees can expect to be paid a salary between $120,960 to $181,440.00. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is merely an estimate and may vary based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors. This posting will be available for application until at least 1/23/2026. #LI-US #LI-AMS YOUR APPLICATION Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Bayer is an E-Verify Employer. Location:United States : North Carolina : Raleigh Division:Pharmaceuticals Reference Code:858993 Contact Us Email:hrop_*************
    $121k-181.4k yearly Easy Apply 10d ago
  • Technician, Operations (Operator w/Mechanical Skill)

    Merck 4.6company rating

    Wilson, NC job

    POSITION OVERVIEW - Basic Functions & Responsibility Essential functions include, but are not limited to: The Technician (Technical), Operations role is an excellent opportunity for individuals with experience in manufacturing and/or packaging operations who are proficient with basic mechanical/electrical equipment troubleshooting, maintenance, and repair. This role will serve as the first responder to challenges that arise with manufacturing and packaging equipment, effectively diagnosing and addressing technical issues. Key responsibilities include following manufacturing and packaging requirements, adhering to Good Manufacturing Practices (GMP), and completing daily tasks according to established procedures under the Operations Manager's guidance while collaborating with team members to ensure safe and timely production of high-quality products. The Technician (Technical) position will operate equipment, setup equipment, perform equipment challenges, monitor quality during production, clean work areas, and move materials accurately and efficiently. The position will also have responsibilities including routine and non-routine equipment / process troubleshooting, process monitoring, and alarm response, all aimed at maintaining operational efficiency and product quality. This position requires a proactive individual with strong technical skills, exceptional attention to detail, and the ability to think critically under pressure. The successful candidate will play a pivotal role in enhancing the operational integrity of manufacturing and packaging processes, contributing to the production of high-quality products in a safe and efficient environment. PRIMARY ACTIVITIES Primary activities include, but are not limited to: + Operations + Operate and maintain various manufacturing and packaging equipment to routinely achieve production standards while following GMPs and SOPs. + Complete effective line clearance, cleaning and inspection including the completion of required documentation. + Setup and adjust the equipment by using appropriate tools to ensure proper alignment and proper clearances. + Maintains and transports all required processing equipment, materials, supplies and products needed to support manufacturing and packaging. + Perform and document equipment challenges per current procedures. + Complete in-process testing and inspections supporting the manufacturing and packaging, validation, and development processes as required. + Act as first responder to equipment malfunctions and process issues; diagnose issues, make necessary adjustments to return the equipment to a functional state. + Escalate any unresolved line issues per established guidelines to ensure efficient operations performance. + Proactively identifies potential production issues and takes action to prevent occurrence. + Assist maintenance personnel with routine and non-routine equipment maintenance and repairs, including helping with performing maintenance tasks, initiating work orders and retrieving parts from the stockroom as required. + Cleans and lubricates machines periodically and performs other basic maintenance work required (ie. wiping off sensors, recharging process fluids, etc.) to assure the efficient operation of all equipment. + Organize, clean and maintain the designated work area to ensure a clean and orderly working environment. + Carry out the Manufacturing Division site mission by assuring finished goods and services are of the highest quality, optimal cost, and delivered on schedule. Compliance + Conducts all manufacturing and packaging operations in accordance with current Good Manufacturing Practices (cGMP), site Standard Operating Procedures (SOPs) and Divisional policies and guidelines. + Follow health and safety policies, including proper gowning procedures and the use of safety equipment. + Take accountability for personal and others' safety by reporting and resolving unsafe conditions. + Strictly adheres to all site policies on personal conduct and attendance. + Promptly identify and report any compliance, environmental, safety, and process deviations as appropriate and escalate to appropriate personnel. + o Actively participate in and complete EHS and quality-related compliance training in a timely manner. + Maintains work area in constant state of compliance with respect to proper housekeeping, material segregation, and personal gowning including required personal protective equipment. + Document manufacturing and packaging activities in accordance with Good Documentation Practices including ensuring data integrity requirements are met Document equipment changes per cGMP procedures within appropriate system. + Assist in the investigation, root cause determination, and CAPA implementation for equipment related compliance discrepancies noted during day to day activities and/or audits. Collaboration and Teamwork + Collaborates with peers and other employees at various levels throughout the organization to achieve company, site and departmental goals. + Maintain a culture of continuous improvement / MPS focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving. + Participate in quality and safety investigations, improvement activities, and projects to improve manufacturing and packaging operation processes. + Attends and actively participates in safety & housekeeping walkthroughs, 5S, GEMBA, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required. + Participates in projects to enhance manufacturing and packaging equipment functionality and operational processes. + Train other team members regarding the basic response for common faults and errors. + Help to develop and improve setup and troubleshooting standard work. + Pursue knowledge and skills in assigned area from an operations and equipment maintenance perspective and share that information readily with team. + Actively identifies and drives problem resolution and implements feasible solutions for opportunities and issues identified by the team. + Participate in new equipment installations by interfacing with equipment vendors, partnering with project engineering on testing/qualification activities, recommending spare parts, and assisting with the review of preventative maintenance plans. SKILLS a) Education Requirements + High School Diploma or equivalent b) Required Skills + More than 2 years of experience in a GMP manufacturing facility. + Experience operating, maintaining, troubleshooting, and/or repairing industrial equipment. + Basic mechanical and electrical system understanding + Demonstrated ability to troubleshoot equipment utilizing a systematic approach to understand problems and determine appropriate solutions. + Demonstrated ability to work independently as team member. + Demonstrated ability to work with computerized and automated systems. + Must be willing and able to lift 50 lbs. + Must be willing to work various shifts. + Must be willing to work irregular hours to support multi-shift operation and/or weekends as needed. c) Preferred Skills + Maintenance experience within a GMP regulated environment + Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies. + SAP / MES / electronic logbook basic knowledge from a production execution perspective + Outstanding communication skills both within direct team and across multiple shifts to ensure success of overall team. \#MSJR VETJOBS The salary range for this role is: $51,500 - $81,100 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. **Required Skills:** Accountability, Accountability, Calibration of Equipment, Compliance Training, Computer Literacy, Equipment Maintenance, Facility Maintenance, GMP Compliance, Good Manufacturing Practices (GMP), Inventory Management, Lean Manufacturing, Maintenance Processes, Manufacturing Quality Control, Mechanical Maintenance, Operational Efficiency, Operations Management, Packaging Management, Packaging Processes, Preventive Maintenance, Process Monitoring, Process Optimization, Production Operations, Production Reports, Production Scheduling, Production Standards {+ 5 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** No Travel Required **Flexible Work Arrangements:** Not Applicable **Shift:** 3rd - Night **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 01/30/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381066
    $51.5k-81.1k yearly 7d ago
  • IT Manager - Manufacturing

    J&J Family of Companies 4.7company rating

    Wilson, NC job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Technology Product & Platform Management **Job Sub** **Function:** Technical Product Management **Job Category:** People Leader **All Job Posting Locations:** Wilson, North Carolina, United States of America **Job Description:** We are searching for the best talent for an **IT - Technical Manager in Manufacturing (Technical Product Owner)** who will lead deployments and support manufacturing site technology solutions from an IT perspective. This role involves managing individual contributors and vendors, developing tactical and operational plans, to support organizational objectives and business goals. The Technical Product Owner will develop roadmaps aligning with strategic technology programs and business needs. The location for this position is **Wilson, North Carolina - USA** and requires all days 5 days on site per week. **Responsibilities** + Product owner for digital product and/or digital site services. Owns product life cycle, product roadmap and deliver of product increments. + Allocates resources to create solutions to business problems and outlines the solutions via clear and executable product requirements. Focuses and prioritizes the team's execution on the most business-critical problems. + Manages individual contributors and vendors. Develops tactical and operational plans to achieve site specific Technology Product & Platform Management goals and communicates plans to managers, supervisors, and individual contributors. + Supports financial planning and controlling. + Supports technology strategy for business partners and develops product roadmaps. + Develops insights for site leadership. Contributes to technology projects, programs, and processes. Creates reports, visualizations or other documents. Presents findings and provides updates on status to team and management. **Required qualifications** + Bachelor's degree + A minimum of 5 years' experience in a similar position + Experience in leading and managing vendors + Experience in a (pharmaceutical) manufacturing environment + Strong understanding of GMP requirements and processes + Strong experience in SDLC process + Substantial skills in manufacturing relevant IT technologies (Digital and Innovation) + Focus on Business agility and challenge thinking + Adept in ISA-95 model + Excellent written and oral communication skills, with strong interpersonal skills and a team-oriented approach. + Adept in financial management **Preferred qualifications** + Experience playing a manufacturing site level role. + Experience in pharmaceutical or life sciences industries. + Experience with manufacturing-related systems (e.g., MES PAS-X, SAP ERP, LIMS, CMMS, Truvault) and ecosystem integration. + Experience in data platforms and solutions (Azure Data Lake, GraphDB, Time Series DB) is a big plus + Experience in integrations technologies (MQTT Brokers, High Byte, Kafka,....) is a big plus + Experience in AI/ML, Model Mgmt, Data Science, Prompt Engineering, MLOps is a big plus + Familiarity with Quality-related systems (e.g Truvault, QMS,...) + Experience in solutioning and architecture. + Familiarity with OT systems and OT integrations (e.g Kepware, DeltaV, PLC,...) + Experience handling Cybersecurity + Experience in Agile, Scrum and Project Management + Understanding of product Lifecyle Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. \#JNJTech **Required Skills:** Good Manufacturing Practices (GMP), Systems Development Lifecycle (SDLC) **Preferred Skills:** Agile Principles, Operational Technology (OT), Product Lifecycle
    $111k-144k yearly est. 10d ago
  • QC Separations Specialist

    J&J Family of Companies 4.7company rating

    Wilson, NC job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Quality **Job Sub** **Function:** Quality Control **Job Category:** Professional **All Job Posting Locations:** Wilson, North Carolina, United States of America **Job Description:** Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine We are seeking an experienced **Separations Specialist** with expertise in **High-Performance Liquid Chromatography (HPLC)** to join our Quality Control (QC) team at a newly established large molecule manufacturing site in Wilson, NC. As one of the first fifteen employees in the QC department, you will play a foundational role in building laboratory capabilities, authoring procedures, and transferring analytical methods in a GMP-regulated environment. J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. **Key Responsibilities** + **Establish QC Capabilities:** Support the build-out of QC laboratory infrastructure and workflows for separations testing. + **Method Transfer & Validation:** Lead comparative testing and transfer of HPLC-based methods for biologics, ensuring compliance with global regulatory standards (FDA, EMA, ICH). + **Procedure Development:** Author, review, and approve SOPs, work instructions, and technical documentation for separations testing. + **Technical Expertise:** Serve as the subject matter expert for chromatographic techniques; train and mentor incoming QC personnel. + **Cross-Functional Collaboration:** Partner with MSAT, QA, and Operations to ensure seamless method implementation and resolve technical challenges. + **Compliance & Quality:** Maintain adherence to GMP, compendial requirements (USP, EP, JP), and site-specific quality standards. Support regulatory inspections and contribute to observation responses. + **Continuous Improvement:** Identify and implement process improvements to enhance efficiency and robustness of separations testing. **Qualifications** + Bachelor's degree in Chemistry, Biochemistry, or related field; advanced degree preferred. + Minimum 6 years of experience in QC or analytical development within biologics or pharmaceutical manufacturing. + Strong expertise in HPLC and related separations techniques. + Proven experience in method validation, transfer, and regulatory compliance in a GMP environment. + Knowledge of compendial standards and global regulatory guidelines. + Excellent communication skills and ability to thrive in a dynamic, start-up environment. **Key Competencies** + Entrepreneurial mindset with a passion for building new capabilities. + Detail-oriented and highly organized, with strong problem-solving skills. + Ability to work independently and collaboratively across functions. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. **Required Skills:** **Preferred Skills:**
    $72k-88k yearly est. 6d ago
  • Senior Building Automation Engineer-BAS Lead

    J&J Family of Companies 4.7company rating

    Wilson, NC job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Supply Chain Engineering **Job Sub** **Function:** Automation Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** Wilson, North Carolina, United States of America **Job Description:** Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine . J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. The GET (Global Engineering & Technology) organization operates as one integrated team in the delivery of Engineering, Maintenance and Execution Systems solutions. We operate in a standard, coordinated and consistent manner in support of the current and future requirements of our Manufacturing and Manufacturing Science and Technology (MSAT) and in partnership with key internal/external network. Apply today for this great opportunity located in Wilson, NC! The selected candidate will lead the delivery, support, and maintenance of site Building Automation System (BAS) and Utility Programmable Logic Controller (PLC) systems, including project execution, upgrades, system performance, vendor management, production and development systems, library standards and network infrastructure. After the go-live, this position will conduct the planning, design, scheduling, and control of automation projects to support new product development and base business. **Key Responsibilities:** + Site primary contact for BAS and Utility PLC global standards supports and delivery. + Delivery and execution of the Site BAS and utility PLC Projects and strategies. + BAS and Utility PLC Technical Owner and SME for the site + Establishes methods for developing and gaining insight into system architecture to distill it into concrete design. + Assists in establishing and implementing automation requirements and is responsible for the scheduling, resource management, maintenance, and operational support. + Delivers technical reports, technical papers, and other documents. + Assists in the management of existing equipment and control systems in assigned areas and helps determine reliability and need for updates. + Conducts most complex assessments to determine regulatory compliance and any necessary improvements for regulation conformity. + Establishes automation, deliverables timelines and ensures adherence to expected deadlines. + Coaches more junior colleagues in techniques, processes, and responsibilities. **Qualifications** **Education:** + A Bachelor Degree in Engineering and/ or an Associates Degree with at least 8 years of experience in automation systems experience ; required **Experience and Skills:** **Required:** + A minimum of 6 years of experience in automation systems + Strong BAS (preferably in Honeywell BMS) and Siemens PLC experience. + In-depth Technical knowledge of BAS both hardware and software components + Experience within a pharmaceutical or GMP regulated manufacturing environment. + Project Management experience. + Good understanding of BAS system architecture and software design + Hands-on experience in managing automation vendors in larger projects **Preferred:** + Key appreciation of Industrial Automation Networks and their Communication Protocols. + Process knowledge for HVAC, facilities, and utility systems. + In-depth understanding of the ISA S95 & S88 standards and how they should be used within the Global Supply Chain + Good appreciation of Industry 4.0/IIoT. + Solid understanding of the developing Digital World to transform Biopharma. **Other:** + _Ability to travel up to 10% of the time, domestic and internationally_ For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ******************* .] Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation. **Required Skills:** Automation, Engineering **Preferred Skills:** Automotive Supply Chain, Building Management System (BMS), Supply Chain, Systems Engineering
    $88k-106k yearly est. 60d+ ago

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