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Medtronic jobs in Raleigh, NC - 71 jobs

  • Sr. Affera Mapping Specialist , CAS - NC

    Medtronic 4.7company rating

    Medtronic job in Raleigh, NC

    We anticipate the application window for this opening will close on - 30 Jan 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life** Job Specific Summary We are seeking a committed professional to join our team. While this is a remote position not located at a physical Medtronic site, the candidate hired will be required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role. Join Medtronic as an Affera Mapping Specialist and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you'll work alongside a collaborative team of clinicians, engineers, physicians, and innovators to execute mapping solutions for cardiac and other electrophysiological systems. By blending technical expertise with a passion for improving patient outcomes, you'll have the opportunity to impact global healthcare directly. If you're driven by precision, problem-solving, and the chance to make a tangible difference in people's lives, this is your opportunity to grow your career while shaping the future of medical innovation at Medtronic. To find all CAS Mapping roles available please use #casmap in the key word search at Medtronic Careers (********************************************************* **Various levels available based on qualifications and experience** Responsibilities may include the following and other duties may be assigned. + Provide clinical and technical support and training to physicians and staff on the EP mapping and navigation system and all CAS products. + Educate and train physicians, hospital personnel and office staff on technical matters relating to CAS products and related procedures. + Promote the safe and effective use of Medtronic CAS products and related procedures. + Understand and support national, regional and territory sales objectives to achieve or exceed sales goals within all CAS products. + Develop and cultivate customer relationships resulting in incremental business. + Work in partnership with Account Manager, Regional Manager and Area Directors to identify potential sales opportunities. + Collaborate and strategize with local sales team to conduct customer training for mapping and other CA Solutions products. + Collaborate and communicate with the sales and clinical teams in the region. + Serves as an effective Medtronic CAS representative to physicians and support staff regarding Medtronic CAS products, service and support. + Serve as a regional champion to share your experience and influence others to be proficient in the mapping technology. The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. We seek out and hire a diverse workforce at every level: We need fresh ideas and inclusive insights to continue to be an innovative industry leader -that's why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients. To learn more about Inclusion & Diversity at Medtronic Click Here (***************************************************************************** **Required Qualifications** _To be considered for this role, please ensure these minimum requirements are evident on your resume._ + High school diploma PLUS a minimum of 8 years of related work experience in cardiac mapping and navigation. **OR** + Associate degree PLUS a minimum of 6 years of related work experience in cardiac mapping and navigation. **OR** + Bachelor degree plus a minimum of 4 years of related work experience in cardiac mapping and navigation. **Preferred Qualifications** + B.A./B.S. Degree in nursing, cardiovascular, life sciences, or technical discipline with minimum of four years work experience in cardiac field, hospital/clinic or sales. + Proven track record with technical training assignments. + Experience in the cardiac catheter ablation field, EP lab, in a hospital/clinic or EP medical sales providing technical / clinical support. + Ability to travel more than 25% of the time **Additional Job Requirements** + Environmental exposure to infectious disease and radiation + Clinical Specialists are required to be within their assigned territory each day to be available as unscheduled needs arise + Clinical Specialists will on occasion be required to travel outside of their assigned territory and possibility overnight + Must have a valid driver's license + Ability to freely move throughout the facility, use a phone, keyboard and mouse, visually able to interact with personal computers + Must be able to stand/sit/walk for 8 hours a day + Ability to travel up to 25% Must have a valid driver's license and active vehicle insurance policy. In addition, your driving record will be reviewed and will be considered as part of your application. Must be able to drive approximately 50% of the time within assigned territory and may require overnight travel. CARDIOVASCULAR PORTFOLIO: Cardiac Ablation Solutions offers cardiac mapping and ablation solutions to treat patients with abnormal heart rhythms. Our vision is to help patients worldwide by advancing innovation for the diagnosis and ablation of cardiac arrhythmias, enabling clinicians to perform procedures with superior outcomes. **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. **Benefits & Compensation** **Medtronic offers a competitive Salary and flexible Benefits Package** A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$130,000.00 - $140,000.00 The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans (************************************************************************************************************** **About Medtronic** We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here (************************* . It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here (*************************************************************************************************************************************** a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will... + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (*********************************** . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email ******************* To request removal of your personal information from our systems please email *****************************
    $130k-140k yearly 10d ago
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  • Sales Representative - Pelvic Health- Raleigh, NC

    Medtronic 4.7company rating

    Medtronic job in Raleigh, NC

    We anticipate the application window for this opening will close on - 18 Jan 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the LifeWe are seeking a committed professional to join our team. While this is a remote position not located at a physical Medtronic site, the candidate hired will be required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role. The Medtronic Interstim Sales Representative will manage territory base business and growth by initiating, supporting and developing strategic implanting centers and assisting in developing key referral networks. In certain geographies, they will also have primary responsibility for development of referral networks. Act as primary account/implanter relationship contact for assigned territory's customer needs including account level reimbursement responsibility. Includes coordination of all support activities and development of sales partnerships with distribution alliances. This is a field-based position. We are seeking a committed professional, required to reside within the territory and drive to multiple accounts throughout the region, to join our winning team. A valid driver's license is essential for this role, which also includes travel outside the territory, presenting opportunities for broader engagement. Responsibilities may include the following and other duties may be assigned: Selling Interstim devices for specific therapies to physicians, institutions, payors, and other appropriate medical staff Partnering with strategic implanting centers to develop the account/implanter practice through; Providing product and therapy technical support and service Including consultation of strategic management and analysis of trends Utilization of appropriate Neuro business partners to present marketing and business plans to accounts for territory development and growth Other activities as they arise, as assigned buy the sales leadership. We seek out and hire a diverse workforce at every level: We need fresh ideas and inclusive insights to continue to be an innovative industry leader -that's why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients. To learn more about Inclusion & Diversity at Medtronic Click Here Qualifications Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident on your resume. • High School Diploma (or equivalent) AND 6+ years of experience* • OR Associate's Degree AND 4+ years of experience* • OR Bachelor's Degree AND 2+ years of experience* *Relevant sales, clinical, or related experience in medical devices, medtech, healthcare, or life sciences Nice to Have: Solid knowledge of the Reimbursement climate Experience calling on physicians in one or more of the following or related referral accounts Neurology, Urology, Colo Rectal Surgeons Experience in developing new, innovative markets; Experience in making multiple referral calls on a daily basis Familiarity with the O.R. Solid job skills in business planning/consulting and territory financial analysis; preferred knowledge of managed care Experience with Physiology/clinical therapies Experience with Implantable devices Excellent interpersonal, communication, negotiation skills Team oriented Conceptual/consultative sales skills Understanding of all quality policy/system items that are applicable Ability to follow all work/quality procedures to ensure quality system compliance and high quality work ** Preference will be given to local qualified candidates and candidates with Medtronic experience Additional Job Requirements: Frequent required travel to customer clinics, hospitals and off-site meetings. The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. The physical demands described within the Responsibilities section of this are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America). Must have a valid driver's license and active vehicle insurance policy. In addition, your driving record will be reviewed and will be considered as part of your application. Must be able to drive approximately 50% of the time within assigned territory and may require overnight travel. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here. Business Description: Pelvic Health is part of the Neuroscience Portfolio. Our therapies treat patients suffering from overactive bladder, non-obstructive urinary retention and fecal incontinence with our sacral neuromodulation (SNM) systems InterStim X™️ and InterStim™️ Micro; and our percutaneous tibial neuromodulation (PTNM) system NURO™️. More than 400 million people worldwide have incontinence, and many of them limit their lives socially, professionally and personally because of their condition. Our goal is to expand access to our therapies so we can help potentially millions of people get their lives back. Click here to learn more about products. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$65,000.00 - $65,000.00The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. Learn more about total rewards here. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
    $65k-65k yearly Auto-Apply 4d ago
  • Senior Production Scheduler, CVRM (Holly Springs)

    Genentech 4.5company rating

    Holly Springs, NC job

    Pharma Technical Manufacturing (PTM) is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche's ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). The Opportunity We're looking for a highly skilled Master Production Scheduler/Senior Production Scheduler to join our team. In this role, you'll be responsible for developing and maintaining the master production schedule, ensuring we meet customer demand while optimizing our production resources. You'll be a key player in our supply chain, bridging the gap between sales, operations, and procurement. As part of plant start-up you will act as the Materials Management PLAN main functional contact for the SAP ERP deployment; responsible for the timeline, deliverables, and adherence to the global template processes. Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase. * You will create and maintain a feasible Master Production Schedule (MPS) for key finished goods and components, balancing customer demand with production capacity. Use inputs from the sales forecast, customer orders, and inventory targets to drive the schedule. * You will assess and manage production capacity, identifying and resolving any bottlenecks. Work closely with production managers to ensure the MPS is achievable. * You will partner with the procurement team to ensure timely availability of raw materials and components needed for production. Monitor inventory levels and adjust the MPS as needed to prevent stockouts or excessive inventory. * You will utilize SAP S/4HANA for planning and execution, and OMP for advanced planning and scheduling. You'll need to be proficient in these systems, generating reports, analyzing data, and making informed decisions. * You will serve as the primary liaison between sales, operations, finance, and procurement. You'll communicate changes to the schedule, manage expectations, and facilitate a smooth production flow. * You will monitor and report on key performance indicators (KPIs) such as production attainment, schedule adherence, and inventory accuracy. Use this data to identify areas for continuous improvement. * You will apply standard APICS (Association for Supply Chain Management) principles and best practices in all aspects of master scheduling. A strong understanding of planning, scheduling, and inventory management concepts is essential. * You will lead site function activities for SAP deployment fit-to-template, design, test, SOP development, go-live, and hypercare Who You Are You hold a Bachelor's degree in Supply Chain Management, Operations, Business, or a related field with 8-10 years in a master production scheduler or similar supply chain planning role.. * You have proven experience with ERP planning processes and software (eg. SAP S/4HANA and OMP) is required. * You have strong analytical and problem-solving abilities, with the capacity to analyze complex data and make data-driven decisions. * You have excellent communication and interpersonal skills, with the ability to effectively collaborate with various teams and stakeholders. Preferred * You have a CPIM (Certified in Planning and Inventory Management) or CSCP (Certified Supply Chain Professional) certification * You have an advanced degree (eg. Masters, MBA) * You have experience with the implementation of large scale ERP projects a plus The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina $91,070 - $169,130. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. Relocation benefits are provided. Link to Benefits Relocation benefits are provided Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $60k-74k yearly est. 60d+ ago
  • Field Clinical Specialist - Raleigh, NC - Inari Medical

    Stryker 4.7company rating

    Durham, NC job

    Work Flexibility: Field-based The Field Clinical Specialist works using independent judgement, partners with local Account Managers to increase clinical support, education resulting in increased clinical acumen. Responsibilities Educate physicians on device handling, implantation and troubleshooting techniques related to Inari products. Develop, lead and/or facilitate training sessions and in-service education programs in the hospital environment. Identify therapy adoption opportunities in collaboration with Regional and Account Managers in local geographies. Communicate highly technical information clearly and effectively during fast-paced procedures. Act as a clinical interface between the medical community and the Company. Demonstrate ability to build and sustain credible business relationships with customers and share product expertise accordingly. Provide education and clinical support in response to the most complex field inquiries on an as-needed basis. Demonstrate a thorough understanding of all Inari products, related products and technical knowledge, trends, and players. Collaborate with product development teams to provide feedback on device features and new device development Document procedural case observations for regulatory requirements and ongoing continuous improvement Other duties as needed. Qualifications Bachelor's degree preferred or Associates Degree in nursing or clinical required Minimum of three (3) years; in medical device clinical capacity or cath lab. Proven understanding of cardiovascular science, cardiovascular anatomy, pathology and physiology Strong clinical acumen is required. Understanding of sales process is a plus. Travel up to 80% of the time - both locally and regionally, and occasionally overnight. Night/weekend on call per preplanned scheduled. Extensive sitting, standing, and speaking. Light lifting to 10 pounds. Must be open to a dynamic work environment which includes regular interaction with several different physician and hospital staff customers in several locations. Must have desire to participate in a healthcare team in the treatment of patients and anticipate needs of others. Apply critical thinking skills to solve complex clinical problems. Excellent command of the English language with comprehensive written and verbal communication, interpersonal, analytical, and organizational skills. Must have the ability to concentrate on detail and work independently and meet deadlines with strong attention to detail Comprehensive computer skills with experience in Microsoft Office with ability to develop presentation materials. Base/Draw + commission: $State established rate or range for salary and may be eligible to earn commission and/or bonuses + benefits. #LI-REMOTE Travel Percentage: NoneStryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain the COVID-19 vaccination as an essential function of their role.
    $94k-130k yearly est. Auto-Apply 6d ago
  • Oncology Account Executive - Eastern North Carolina

    Hologic 4.4company rating

    Raleigh, NC job

    Biotheranostics, a Hologic company, develops and provides molecular-based diagnostic, prognostic, and predictive tests that support physicians in the individualized treatment of cancer patients. Discover a career as an Oncology Account Executive where you can connect clients with the right products, expand new territories and impact lives daily. From oncologists to lab personnel, pathologists to nurses, you will be helping to nurture our relationships with our key customers. Think this role is for you? Using your in-depth knowledge of our products, Breast Cancer Index and CancerType ID tests, you will help to develop and implement an effective territory business plan, that will target the top academic medical centers and community-based oncology practices in your region. You will also look at the national and regional opinion leaders in both academic and community settings, making sure you cover all bases. Key Outcomes: As an Oncology Account Executive, you will take charge and develop complete ownership of your territory and territory relationships. You'll be memorable, especially when it comes to regional and national training programs, conventions, and symposia. Most importantly, using your knowledge of oncology, and leveraging our regional Field Science Liaison, you will be sharing effective scientific presentations to our customers. Do you have what it takes? Having a strong understanding of life sciences and molecular diagnostics, specifically for breast and general oncology, is important. With this, you will be able to guide our customers to finding the right products to help their patients. Using your excellent knowledge of the hospital and cancer center environments, you'll be able to adapt and evolve to meet your potential customer's needs. Join us as an Oncology Account Executive and discover how you can help organizations provide the right care, every time. Additional qualifications and information * Bachelor's Degree (Science degree preferred) * 5+ years of diagnostics or medical sales experience; oncology preferred * Valid driver's license required * 50% travel required within sales region, as well as corporate meetings, trade shows and special events The total compensation range for this role is $220,000 - $230,000. This is based on a base salary and commission plan combination. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, territory/ geography, education, business needs, market demand and performance versus quota. Agency And Third Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic's employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-JM1 #mid-seniorlevel #remote
    $220k-230k yearly 54d ago
  • Project (Client Services) Manager

    Genentech 4.5company rating

    Holly Springs, NC job

    ** A healthier future. That's what drives us. Always innovating, we bring together dedicated people and diverse perspectives from across our global network, empowering each other to keep breaking new ground. That's what makes us who we are. That's what makes us Roche. This role is based in Pharma Technical Operations Technology (PTT), an organization that is responsible for ensuring Pharma Technical Operations (PT) stays at the forefront of technology in our current and future facilities. PTT, composed of global MSAT and Engineering, realizes new assets for the PT manufacturing network of drug substance, drug product, and device industrialization facilities. You will have the opportunity to build manufacturing facilities that deliver life saving medicines to patients. **The Opportunity** As a project manager, within the capital delivery group, you will be responsible for leading large and/or complex facility/equipment improvement projects within our US manufacturing network as well as potentially at our international sites. For this specific opportunity, you will be part of the project management team delivering our new greenfield drug product campus (>$1bn), from basic design through qualification. Post implementation you will support projects both in Holly Springs and our other US locations. + Build and lead the project team, motivating them through your strong communication and leadership skills with clear decision-making to maintain project flow. + Model collaboration through strong partnership with User Team Lead and other key customers. + Champion both design and construction safety as a key priority, engaging the Safety, Health, and Environment team throughout the project lifecycle. + Accountable for fiscal control of the project by + managing funding in alignment with execution strategy, using lean principles + engaging directly with the project controls team to keep them informed + managing scope and schedule of the capital project within the agreed business case + Stakeholder management is required + Keeping the team focused on execution plan + Engage with the internal and external project team members from AE's, CM's, and trade partners to resolve any impediments that arise and to ensure a quality final deliverable. + From early concept, through design, construction and commissioning and qualification,, deliver the project not relenting until the project's business intent is actually met. **Who you are:** + B.S. in engineering or construction management with a minimum of 10 years successfully managing projects in the biotech/pharmaceutical industry, with at least 3 years managing mid sized, complex construction projects, some possibly in an international environment. + Known for your exceptional interpersonal and leadership skills in capital project delivery. + Proven expertise in effectively applying and/or developing advanced project management tools and methodologies. + Broad understanding of the principles of various engineering disciplines, in-depth understanding of one engineering discipline directly related to Roche core business of biopharmaceutical manufacturing. Preferred: + MS in Engineering and/or an MBA and/or a PE/equivalent + Special knowledge requirements include biopharmaceutical and pharmaceutical processes and facility design approaches, plus solid understanding of Pharmaceutical cGMP requirements and guidelines. + Understanding of risk based qualification + Lean Construction knowledge and practitioner Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of North Carolina is $119,900 to $222,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. **Benefits (****************************************************** \#LI-PK1 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
    $119.9k-222.7k yearly 60d+ ago
  • Quality Technician 2

    Intuitive Surgical 4.9company rating

    Durham, NC job

    It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies-like the da Vinci surgical system and Ion-have transformed how care is delivered for millions of patients worldwide. We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life. If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here. Job Description Primary Function of Position This role is responsible for performing visual, dimensional, and functional inspections of Advanced Tissue Models finished goods. This position ensures quality specifications have been met prior to release to finished goods. Essential Job Duties * Perform finished goods inspections per approved procedures in a timely manner. * Use measurement tools, templates, and guides as described in approved procedures. * Verify finished goods labels for accuracy and legibility. * Support investigation and documentation of defects/non-conformances. * Participate in first article and sampling inspection activities, as directed. * Contribute to safety and process improvement initiatives. * Handle product in accordance with procedures to prevent mix-ups, damage, or other adverse effects. * Record transactions in SAP and move materials to stock locations. * Communicate inspection results to production and engineering teams, as needed. * Coordinate Material Review Board (MRB) process. * Assist engineering on failure investigations, report findings/results and process improvements. * Follow all corporate, safety, production procedures and regulations. * Coordinate with cross-functional teams on product flow prioritization. * Perform other duties as assigned. Qualifications Qualifications Required Skills and Experience * Ability to read drawings and specifications * Ability to use basic inspection tools as required. * Proficient in use of personal computers as part of daily work, including knowledge of the Microsoft Office suite, SAP and ACCS (Agile) system to retrieve and submit on-line documentation * Knowledge of Good Manufacturing Practices (GMP) * Maintains a neat and orderly workstation * Ability to maintain excellent communication with stakeholders and foster quality culture. * Demonstrates high level of accuracy and attention to details. * Maintains an excellent attendance record Required Education and Training * High school diploma or equivalent. * 1-3 years related experience or training; or equivalent combination of education and experience. Working Conditions * Ability to lift and carry up to 10 lbs. Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
    $40k-52k yearly est. 6d ago
  • Senior Principal IT/OT Infrastructure Engineer (CVRM)

    Genentech 4.5company rating

    Holly Springs, NC job

    ITOT supports Pharma Technical Manufacturing (PTM), PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche's ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). The Opportunity A Senior Principal ITOT Infrastructure Engineer is being hired to participate in Greenfield Project execution and then support the facility after going live. Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase. What You'll Do Senior Principal ITOT Infrastructure Engineer (Department: ITOT/Infrastructure - Leadership Role) will be Responsible for providing IT Infrastructure engineering capabilities and experience to the ITOT Group including generating qualification protocols and maintaining the validated state of systems and processes. Initially, participates in Basic Design, Detailed Design and Facility Startup focussed on data center and filed IT infrastructure. Eventually focuses on providing long-term support for newly built facilities with respect to the Infrastructure for process, utility and building systems. Lead Infrastructure impacting projects with large and/or complex scope. Drive strategic initiatives to improve business processes. Be both a People Leader/ Coach and at times hands on SME. Act as Cyber Security Coordinator / Engineer. Provide basic IT support for Site workplace needs in collaboration with Global IT groups. * Site Owner of "OT Infrastructure" for Manufacturing System Platforms including Syncade MES, DeltaV Distributed Control System, PLC's, Lab Data Systems (Smartline Data Cockpit) * Site Lead for Global Cyber Security Initiatives * Site OT Infrastructure Support Lead and Coordinator with Global Infrastructure solutions at site (e.g. support of AD and firewall policies to allow proper access and communication from either AD security or network firewall policies, and commissioning and startup support) * May eventually expand role to become Regional OT Infrastructure Lead for multiple sites supporting ITOT operating model evolution * Collaborate with IT Engineers and Architects, Automation Engineers * Lead and/or provide support for the evaluation, installation, and maintenance of Manufacturing infrastructure including installation and upgrade of control systems hardware, software, control networks, user administration, database administration, security, system monitoring, backup and recovery of Microsoft Windows Server Operating Systems and SQL Databases * Lead and/or support implementation of OT infrastructure standards and best practices across all Site OT and Process Automation platforms, working with other process automation engineers, IT and OT professionals. * Support commissioning and startup activity of new process control systems and manufacturing systems (Syncade, DeltaV, PLC's, OSI PI historian, etc). * Be the go to Infrastructure expert at the site who bridges the gap between Automation and underlying Storage Compute and Network infrastructure * Execute control system virtualization administration, user administration, system monitoring, capacity planning, design, installation, configuration, and upgrade of platform. * Execute computer system validation and control system lifecycle management. * Produce and review design drawings and specification documents (URS, FS, DS, etc.). * Support end-to-end system qualification, including test creation, execution, review and approval. * Manage personal project activities (design and qualification) following Genentech/Roche business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget. * Review and approve vendor information packages, including drawings and specifications as directed to ensure user requirements are met. * Support plant operations to assess discrepant events and changes for automation impact, deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings. * Author and then Adhere to site SOPs and work instructions for daily and project deliverables. Drive improvements to business processes. * Support inspection activities to present automation design and qualification deliverables and strategy (e.g. Qualification Project Plans and Master Plans). * Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines. * Automation lead for equipment/software FAT, field testing and commissioning * Provide scope, qualification, resource, and budget estimates for automation impacting projects. * Manage employees/ contractor staff, track project deliverables, and provide status updates to the project team. * Manage teams (contractor and FTE staff) by setting clear expectations for work delivered and behaviors. Monitor performance and ensure contractual obligations are met. Complete timely review of time sheets and invoices. * Provide input into network/global business processes and procedures (e.g. GSPs). * All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA). * Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area. Fosters a positive safety culture in which no one gets hurt. * Support work of the Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting. Who You Are * Bachelor's degree in Engineering, Computer Science, or equivalent experience. * A minimum of 5 years systems engineer experience involved in the design, implementation, and/or support of automation systems, preferably in a regulated (Pharmaceutical) industry. * 24X7 support, participate in an on-call environment to meet business continuity requirements, including weekends and holidays as required. * Experience with Operating Systems, Virtualization, LAN/WAN, Firewalls, SQL Servers client-server and terminal virtualization as a System Administrator * Certifications: Certified Information System Security Professional (CISSP), ISA/IEC 62443 Cybersecurity Specialist certification, Global Industrial Cyber Security Professional (GICSP) is a plus Knowledge, Skills and Abilities * Experience with Biopharmaceutical manufacturing, design or/and construction. * Knowledge of Industrial Ethernet networks for manufacturing. * Knowledge of vision systems * Knowledge of Drug Product Manufacturing processes including aseptic or robotic fillings systems, vial handling, environmental monitoring and clean utilities. * Knowledge of communication protocols for devices (OPC, Modbus, MQTT, Ethernet IO, IOT) * Knowledge of integration and data transfer with Level 2, 3, and 4 systems. * Qualification experience related to control and computer systems. * Ability to generate engineering drawings and specifications. * Demonstrate strong organizational, communication, and interpersonal skills to effectively manage tasks and collaborate with diverse teams. * Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility. * Demonstrate strong working knowledge of PC based programs and web based systems. * Ability to work independently with no direct supervision. * Knowledge of GAMP5 * Work in a standard office environment. * May work in the clean room environment that requires gowning in the form of hospital scrubs, coveralls, gloves and steel toe boots. No make-up or jewelry can be worn when working in the clean room environment. * May work with hazardous materials and chemicals. Relocation funding is available for this role. The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $114,400 - $212,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $114.4k-212.4k yearly 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 16h ago
  • SAP System Process Specialist (CVRM)

    Genentech 4.5company rating

    Holly Springs, NC job

    ITOT supports Pharma Technical Manufacturing (PTM), PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche's ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). The Opportunity A System Process Specialist is being hired to participate in Greenfield Project execution and then support the facility after going live. The role will become member of SAP deployment team for Holly Springs and post go live become site first level support. Candidate will bring experience from one or more of following L4 business processes: EWM (Warehouse), Make, Plan, Asset, Quality Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase. What You'll Do A Systems Process Specialist acts in the 1-Stop-Shop and is part of the support, continuous improvement and onboarding and adoption value streams. The Systems Process Specialist has a profound process understanding and is collaborating with the Business Support Community to continuously improve business processes and underlying IT applications. By this, he/she acts as a trusted adviser of the end-user for any kind of inquiry as well as a bridge between the end user and other roles in the various support layers and can raise incidents on behalf of the user area or work with managers to train users . The role is specialist on a specific operation process area and is providing end-user support based on in-depth and long time professional experience in this domain. Examples of domains include Plan, Make, Quality, EWM (Warehouse), Assets etc. In projects the Systems Process Specialist can also represent the interests of the systems user group and has the responsibility of coordinating and bringing input from the area of responsibility to the project and communicating project goals, information and progress back to the business areas. End User Operation Support * Performs Level 1 On Site/Remote support and troubleshooting of applications, primarily focused on SAP R3 and ASPIRE but could expand to PI, MES, etc. * Acts as Point of Contact for End User/business stakeholders in terms of business requests and IT related issues. * Triages, prioritizes requests and tries to identify the nature / root cause of an issue (handling issue, data issue, authorization issue, IT issue). * Distributes application issues and non-application issues that cannot be solved by him/her to the 2nd level and/or Global Team support. * Coordinates end user groups and escalation management. Follows up on IT Service tickets to resolve issues in a timely manner. Supports issue clarification on request of 2nd level and/or Global Team support. * Validates the resolution proposals and performs the necessary test in case tests are required. * Cooperates with 2nd level and/or Global Team support during analysis of reported incidents. * Maintains close coordination and communication with End User/site business stakeholders for major incidents. * May be a role owner for local roles. * Performs interface monitoring (business errors). * Executes complex or critical system actions. * For new IT initiatives/product/system roll out/Go Live to site, provides on site/remote on call support per business requirement such as adopting business shift pattern during initial roll out and stand down to remote On Call post Hyper Care after successful roll out. * Supports Global/Enterprise and Local ITOT application/systems. * Supports site audits and inspections, planned/unplanned events, and implementation of corrections, etc. as a Subject Matter Expert. * Provides 24x7 routine operation service support per Service Level Agreements to business. * Adheres to the requirements specified in IT related Roche's quality policies/quality standards or related SOP. Continuous Improvement * Supports/Leads Continuous Improvement opportunities related to ITOT applications/system. * Regular exchange with the Support network and or BPMs on support cases, best practices and process improvement proposals with network relevance. * Helps the End User to submit new ideas for process improvements, allowing a comprehensive approach for assessing both the process interdependencies as well impact to all underlying systems. * Describes the full lifecycle of an integrated Change process to Business Process with System impact. This Framework combines the Assessment of the requirement, Build and Test work as well as Deployment and eventually delivery of the added value to the End User. * Embodies PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives. Onboarding & Training * Coordinates and conducts End User training. * Supports user authorization workflows (e.g. request, verify training, approve). * Adds information to the knowledge base. * Creates/Reviews Knowledge Articles. * Creates/Reviews training material. * Initiates knowledge management process. Who You Are * Bachelor's degree in Informatics, Engineering, or equivalent. * 5+ years of experience with SAP R3. * Experience or familiarity with ASPIRE is a plus. * Must have experience in biotech/pharmaceutical manufacturing GMP domain. * Knowledgeable about integration with enterprise business systems (SAP, MES, LIMS, etc.) and data integrity concepts. Soft Skills * Strong analytical skills for effective troubleshooting and problem solving. * Candidates must be self-driven and able to work well with others as a team member. * Strong technical writing and verbal communication skills. * Excellent customer service skills and delivery through agile mindset, stability, flexibility, and speed. * Passion for learning and sharing/leveraging best practices. * Eager to explore new technology and have the ability to learn new concepts. Relocation Funding is not available for this role. The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $80,500 - $149,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $80.5k-149.5k yearly 60d+ ago
  • Operations Supervisor

    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: Customer Management Job Sub Function: Customer Service Operations Job Category: People Leader All Job Posting Locations: Orlando, Florida, United States of America, Phoenix, Arizona, United States, Pittsburgh, Pennsylvania, United States of America, Raleigh, North Carolina, United States 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 searching for the best talent for an Operations Supervisor overseeing PSC Customer Experience Inbound Call Team to located in Pittsburgh, PA; Raleigh, NC; Orlando, FL; or Phoenix, AZ. Purpose: The Operations Supervisor will oversee daily operations, ensure superior service delivery, and support a team of direct reports. You will play a critical role in enhancing the efficiency and effectiveness of our healthcare operations, ensuring we meet the needs of our patients while maintaining the highest standards of quality and compliance. Responsibilities: * Supervise, coach, and mentor a team of direct reports, ensuring excellent patient service. * Oversee the onboarding of new hires, and identify training needs to enhance ongoing skills and productivity. Collaborate with training team for upskilling. * Monitor team performance through key performance indicators (KPIs) and metrics, conduct regular performance discussions, set performance goals, and ensure team compliance with policies and healthcare regulations (e.g. HIPAA) * Work closely with key business partners to achieve program goals, develop SOPs and ensure compliance. * Manage staff scheduling and maintain data quality standards based on program metrics. Implement and enhance operational processes for accuracy and efficiency. * Collaborate with leadership to create program SOP's, WI's and job aids and ensure implementation as required. * Review and update call guides for assigned programs as required. * Partner with leadership to create and implement quality assurance measures ensuring adherence to processes, procedures, and patient confidentiality. * Handle escalated patient concerns and logistical issues promptly, ensuring timely resolutions and maintaining patient satisfaction. * Track operational metrics, prepare regular reports for management, and provide recommendations for workflow improvements and process enhancements. * Review and provide periodic updates and process improvement recommendations to internal stakeholders regarding operations, trends, and overall status of program. * Identify inefficiencies and recommend improvements in workflows, systems, and procedures to increase productivity and improve the patient experience. Work with cross-functional teams to implement new strategies and best practices. * Other duties as assigned. Required Qualifications: * Bachelor's Degree in Healthcare Administration, Business Management or related field. * Minimum of years working experience with 3 years experience in a supervisory role in a high volume call center environment, ideally within the healthcare industry. * Strong understanding of call center operations, KPIs, and healthcare regulations. * Proven leadership skills with the ability to inspire and motivate a team, while also maintaining accountability. * Proficient with using call center software, CRM tools, and Microsoft Office Suite. Preferred Qualifications: * Ability to exercise independent judgment. * Ability to manage deliverables in a fast-paced environment. * Exceptional customer focus, collaboration, initiative, results-oriented, business solution-oriented capabilities #Li-Remote 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: Call Center, Supervisory Management Preferred Skills: Consulting, Customer Analytics, Customer Centricity, Customer Engagement, Customer Relationship Management (CRM), Customer Support Operations, Customer Support Platforms, Customer Support Policies and Procedures, Customer Support Trends, Developing Others, Inclusive Leadership, Leadership, Problem Solving, Process Optimization, Quality Services, Service Excellence, Standard Operating Procedure (SOP)
    $70k-92k yearly est. Auto-Apply 3d ago
  • Senior Principal MES Engineer (CVRM)

    Genentech 4.5company rating

    Holly Springs, NC job

    ITOT supports Pharma Technical Manufacturing (PTM), PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche's ground-breaking therapies to more than 120 million patients around the world. We make our medicines at nine sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). The Opportunity A Senior Principal MES Engineer/ Leader is being hired to participate in Greenfield Project execution and then support the facility after going live. Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase. What You'll Do The Senior Principal MES Engineer will be responsible for providing Manufacturing Execution Systems (Pharmasuite MES) capabilities and experience to the ITOT / MES Group including generating qualification protocols and maintaining the validated state of systems and processes. Initially, participates in Basic Design, Detailed Design and Facility Startup. Eventually focuses on providing long-term support for newly built facilities with respect to the manufacturing execution systems for process, utility and building systems as appropriate. Lead MES impacting projects with large and/or complex scope. Drive strategic initiatives to improve business processes. * MES System implementation including System architecture components and Recipe Authoring for drug product manufacturing processes in GMP environment * Co-create MES strategy and roadmap with business partners (Business Process Owner/Manager, Site Stakeholders and Global MES Core Product Owner) in collaboration with IT Partners (Architects, Global Infrastructure, Business Analysts and MES Core Product Manager) plus external vendors. * Produce and review design specification documents (URS,PRS,FS, DS, etc.). * Support end-to-end system qualification, including test creation, execution, review and approval. * Manage personal project activities (design and qualification) following Genentech/Roche business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget. * Support plant operations to assess discrepant events and changes for automation impact, deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings. * Author and then Adhere to site SOPs and work instructions for daily and project deliverables. Drive improvements to business processes. * Support inspection activities to present automation design and qualification deliverables and strategy (e.g. Qualification Project Plans and Master Plans). * Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines. * MES lead for equipment/software FAT, SAT, field testing and commissioning * Provide scope, qualification, resource, and budget estimates for MES impacting projects. * Manage employees/ contractor staff, track project deliverables, and provide status updates to the project team. * Manage teams (contractor and FTE staff) by setting clear expectations for work delivered and behaviors. Monitor performance and ensure contractual obligations are met. Complete timely review of time sheets and invoices. * Provide input into network/global business processes and procedures (e.g. GSPs). * All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA). * Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area. Fosters a positive safety culture in which no one gets hurt. * Represent and mitigate MES dependencies as related global systems evolve their business processes and technologies (e.g. SAP upgrade & LIMS replacement). * Accountable for MES Support team in a 24/7 GMP Manufacturing environment * Lead teams/ Provide 24/7 on call support for Manufacturing Computerized Systems (GMP) * Work to identify opportunities to create additional value and improve business processes and patient outcomes, maximize the benefits of standardization of technologies and leverage across sites. * Determine business criticality and product quality requirements, and in collaboration with Delivery Service Managers, ensure appropriate service levels, Disaster Recovery procedures, governance, change management, compliance and operational support. * Lead or coordinate technical discussions and vendor negotiations. * Lead proposal development for local and global digital governance bodies, collaborate with Site IT Business Partner to meet the needs of the Holly Springs Manufacturing. * Through Agile delivery model, provide leadership, technical expertise and local implementation experience as a member of Build and Run Squads. * In collaboration with IT Business Partners, monitor and improve stakeholder and user experience and ensure strong support of Product Transfers and Make/Assess/Release. * Lead people: Site MES Lead with People Leadership responsibilities for all site MES Engineers Who You Are * Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 10 years experience, or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 8 years experience. * Minimum of 5 years Pharmasuite MES experience, preferably majority in drug product function * 24X7 support, participate in an on-call environment to meet business continuity requirements, including weekends and holidays as required. Knowledge, Skills and Abilities * Deep expertise with MES System implementation and Recipe Authoring, preferably in PharmaSuite MES * Biopharmaceutical or similar Manufacturing domain. * Knowledge of informational and operational technologies (IT OT), MES integration to enterprise systems. * Knowledge of Manufacturing Execution System, Manufacturing Automation, MES integration with enterprise systems like LIMS, Data Historian, ERP etc. * Knowledge of new product introduction, supply chain and manufacturing operations as applicable to MES. * Keep abreast of key Manufacturing IT trends and be curious - Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc. * Nurtures and develops a business savvy consultative and value-driven partnership with key stakeholders * Exhibits intellectual curiosity and integrity and has a strong passion to bring value-adding technology to the business. * Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles. Relocation funding is available for this role. The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $114,400 - $212,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $114.4k-212.4k yearly 60d+ ago
  • Senior Embedded Software Engineer

    Intuitive Surgical 4.9company rating

    Durham, NC job

    It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies-like the da Vinci surgical system and Ion-have transformed how care is delivered for millions of patients worldwide. We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life. If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here. Job Description Primary Function of the Position The Senior Embedded Software Engineer will work with a group of talented and dedicated people to improve and extend Intuitive's surgical robotic product lines. The successful candidate will contribute to the Product Engineering Software Engineering Group, with focused contribution on embedded software for da Vinci Surgical System products. As a member of the team, you will be involved in delivering features to the surgical customer by integrating complex functionality into complete surgical robot solutions and seeing these through to product release as well as resolving issues after release if necessary. The successful candidate must excel in a high-energy small, focused team environment, be able to drive to solutions from rough requirements, and have a commitment to high product quality. Quick learning and a desire to understand requirements and create solutions are essential to become a valuable integrator and system developer. A strong sense of shared responsibility and shared reward is required, as is the ability to make work fun and interesting. Supporting you will be a development and management team that knows and cares about what you are doing and wants you to succeed. Essential Job Duties * Contribute to the development of software risks, hazards, mitigations, requirements, specifications, designs, reliability, modularity, extensibility, and verification & validation. * Ability and desire to read and understand a legacy codebase that includes low-level and multi- processing heterogeneous networked processors. * Develop new features and investigate and resolve design issues. * Collaborate with other engineering disciplines and groups. * Support field service and manufacturing organizations. * Contribute to multiple areas of software development for our distributed multi-processor systems, including but not limited to the following areas: o Video and/or servo hardware control and monitoring. o Inter-processor communication subsystem development. o Extension of current processing frameworks to new processors and hardware designs. o System diagnostic and service application development o User interface development. o Control and integration of external OEM devices. o Development of research prototypes used to evaluate new product concepts. o Contribute to the definition and specification of future designs. o Support root cause analysis and issue resolution for released products and products in production. Qualifications Required Skills and Experience * Experience developing embedded software in C/C++. * Experience with Matlab, Python, or other scripting languages. * Experience developing cross-platform software * Experience with bare metal, real-time operating systems, and multithreaded programming. * Experience in low level driver development in embedded platforms. * Experience working with circuit board schematics and component data sheets. * Excellent debugging skill and strong ability to root cause and isolate system issues. * Experience in all phases of software development including evaluation, planning and definition, design & implementation, Verification & Validation, Market Launch, and Post Market. * Experience in working and supporting manufacturing organizations. * Ability to build and maintain relationships across supported organizations. * Excellent communication and documentation skills. * Experience with build systems such as Bazel, GNU Make and CMake, EMake. * Experience with revision control systems such as Git and SVN. Required Education and Training * Bachelor/Master/PhD degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science or equivalent work experience. * 8+ years industry experience in developing and supporting embedded systems. Working Conditions * None Preferred Skills and Experience * Experience designing software products in an FDA or other regulated industry. * Experience with hardware design. * Experience with UI design. * Experience with QNX, QML, and Qt. * Experience with Verilog/VHDL to read and understand designs. Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
    $93k-113k yearly est. 41d ago
  • QC Lab Services Manager

    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: Quality Job Sub Function: Quality Control Job Category: Professional 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 We are currently seeking a Quality Control Lab Services Manager, to join the Quality Team for the new Johnson & Johnson Large Molecule Drug Substance Manufacturing facility in Wilson, North Carolina. While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%. 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 QC Lab Services Manager is responsible for leading the Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management and CSV support coordination, among others. Key Responsibilities: * Responsible for the Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management and CSV support coordination, among others. * Perform budget support as the point of contact for activities related to CAPEX, CIP tracking /reporting and spend tracking and reporting. * Support and facilitate the performance management and laboratory planning processes through the laboratory scheduling/planning tools, reporting scorecard metrics and monitoring laboratory indicators. * Lead QC project activities to introduce new products, technologies and computer base applications to improve laboratory efficiency and promote culture of Innovation. * Connect with the QC Global organization being the point of contact for the different center of excellence for equipment and information technologies. * Manage the development of a long-term vision and strategy for these quality systems in close cooperation with the site leadership and translating these strategies into compliant programs and processes in line with regulations and business expectations. * Responsible for the site's Management Review program including the Quality metrics program, to ensure and proactively enhance compliance and business performance of the site. * Responsible for hiring, managing, leading, and motivating the Quality Systems team; inclusive of mentoring, training, and development of department employees. * Manage the resolution of unexpected complex compliance or quality system issues as they arise * Keep abreast of regulatory changes and industry best practices related to laboratory services and ensure timely implementation of necessary updates. * Manage relationships with external regulatory agencies and auditors, supporting inspections and audits, as required. * Drive a culture of quality throughout the organization, promoting a proactive approach to quality management and fostering a continuous improvement mindset. * Support the development of the Quality department budget in line with routine business planning cycles. Qualifications Required: * Bachelor's degree in a scientific or engineering discipline. * Minimum of 6 years of experience working within the biological and/or pharmaceutical industry. * Experience in a Quality leadership role. * Analytical equipment qualification experience. * Experience working with Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management, systems and/or CSV support coordination. * Deep understanding and experience in application of global regulatory (FDA, EMA, ICH, etc.) guidelines in a biological or pharmaceutical manufacturing environment. * Experience interacting with health authorities and taking a leading role in regulatory inspections and audits. Preferred: * Experience in supporting functional area (e.g., Manufacturing, Technical Operations, Engineering & Maintenance, R&D, etc.). * Certification in quality management systems (e.g., Certified Quality Manager, Certified Quality Auditor). * 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 and communicate complex quality concepts to stakeholders at all levels. * Strong analytical and problem-solving skills, with a track record in leading investigations and implementing effective CAPAs. * 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. * Results-driven leader who commits to stretch goals and delivers results. Note: This position description is a general guideline; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs. If you are passionate about quality management in the pharmaceutical industry and possess the necessary skills and experience, we invite you to apply for this exciting opportunity as a QC Lab Services Manager. Join our team and contribute to the development of life-saving therapies in a dynamic and rewarding environment. 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:
    $89k-115k yearly est. Auto-Apply 16h ago
  • Reimbursement Specialist

    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: Customer Management Job Sub Function: Customer Service Operations Job Category: Business Enablement/Support All Job Posting Locations: Orlando, Florida, United States of America, Phoenix, Arizona, United States, Pittsburgh, Pennsylvania, United States of America, Raleigh, North Carolina, United States 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 searching for the best talent for a Reimbursement Specialist to be in Pittsburgh, PA, Raleigh, NC, Phoenix, AZ, or Orlando, FL. Purpose: The Reimbursement Specialist (RS) is a professional role that handles payer inquiries, manages benefit investigations to determine patient eligibility and coverage, and addresses coverage challenges. This role serves as the main contact for payers and collaborates cross-functionally to support the patient service program. Responsibilities: * Assess and analyze patient benefits in coordination with internal program operations, insurance providers, and specialty pharmacy liaisons. * Work independently to complete assigned work in accordance with Standard Operating Procedures and defined service levels to review benefit verification process, resolve coverage challenges, and answer inquiries. * Use high-level problem-solving skills to research cases and resolve independently using creativity, innovation, and professional judgement to make sound decisions. * Maintain frequent phone contact with payers to gather all necessary information related to case/patient information, insurance coverage, prior authorization (PA) and appeals processing. * Efficiently process patient and prescriber requests to accelerate access to therapy. * Serve as expert on payer trends, product access, and reporting reimbursement insights and/or delays, i.e., denials or delays. * Frequently communicate with program management on new insurance requirements and trends. * Collaborate with internal & external stakeholders by providing reimbursement information as needed * Maintain accurate, compliant documentation and communication to support program goals. * Uphold patient privacy laws and foster collaborative team relationships. * Other duties as assigned. Required Qualifications: * High school diploma or equivalent. * Minimum of 2 years of experience in case management or insurance roles preferably within a pharmacy, HUB, or healthcare setting. * Experience using an outbound calling platform to make external calls * Ability to independently manage case load, prioritize work, and use time management skills to meet service level agreements * Ability to efficiently navigate multiple screens and systems to perform work. * Ability to work assigned 8 hr shift between program operating hours of 8am-8pm EST. * Proven ability to manage a case load, prioritize tasks, and build relationships. * Apply company policies and procedures to resolve challenges * Ability to proficiently use Microsoft programs. * Ability to thrive in a regulated, remote, high-volume environment Preferred Qualifications: * Undergraduate Degree * Understanding of plan types - Government, Commercial, Medicaid, VA, Fed * Knowledge of insurance structure (ex PBM's, major medical plans, co-pay assistance /cards) * Working Knowledge of Third-Party and other Foundation programs * Basic understanding of Co-Pay Assistance * Understanding of HUB patient journey, workflow, and triage is a plus. * Possess a strong understanding of biologic/specialty pharma market and patient access challenges #Li-Remote 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: Preferred Skills: Accountability, Communication, Customer Analytics, Customer Centricity, Customer Service Philosophy, Customer Support Operations, Customer Support Platforms, Customer Support Policies and Procedures, Customer Support Trends, Detail-Oriented, Inquiry Handling, Issue Escalation, Order Processing, Process Oriented, Service Excellence, Service Request Management
    $50k-62k yearly est. Auto-Apply 5d ago
  • Medical Inventory Specialist - 1st & 2nd Shift - Raleigh, NC

    Baxter 4.2company rating

    Raleigh, NC job

    This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your Role at Baxter THIS IS WHERE you build trust to achieve results! Are you passionate about starting a career in the medical device field? This is where your passion is able to blossom into an exciting new career. This is where we apply your troubleshooting skills to medical devices and ensure our products are functioning accurately. This is an on-site position where the candidate will be reporting to Wake Medical Hospital. Shift/hours include: - Monday 1st shift (7am-3:30pm)- Wednesday -Friday 2nd shift (3pm-11:30pm) and Saturday mid shift (11am-7:30pm) Your Team This role supports the Baxter mission to save and sustain lives because of the importance of these devices and the help they give to the hospital staff Responsible for both quality and quantity of work: Participate in team activities and problem solving sessions as required. Communicate problems and/or solutions to appropriate person. Report any faulty equipment or unusual conditions to the hiring manager. Must follow processes and procedures as written. As needed, document and/or chart data to aid in problem identification, quality feedback and production scheduling. Train, teach and assist other operators in their duties as required to ensure a quality product and smooth flow. Including the knowledge you will gain with the training from our phenomenal team comes an assortment of excellent benefits such as annual bonuses, paid time off and parental leave. We believe you matter here no matter the role at Baxter! What You'll Be Doing The primary duties of a Medical Equipment Inventory Handler include a high level of customer service to our patients and clients, in addition to picking up and delivering medical equipment in a hospital environment. The ability to walk for long periods of time throughout the day. Being able to push and pull beds.(up to 75lbs) Following hospital standards and protocols while providing excellent customer service and interpersonal skills. Strong analytical and problem-solving skills; enjoy working in a team environment while being self-motivated What You'll Bring You must be at least 18 years of age. High School diploma or GED required. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. To that end, this position has a base hourly range of $16.15 - $24.23. The actual salary may vary based upon several factors including, but not limited to, relevant skills/ experience, time in role, business line, and geographic/ office location. US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
    $16.2-24.2 hourly Auto-Apply 60d+ ago
  • QA Specialist, C&Q/CSV

    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: 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 Auto-Apply 16h ago
  • IT Manager - Manufacturing

    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: 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. Auto-Apply 16h 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
  • Sales Representative - Pelvic Health- Raleigh, NC

    Medtronic Inc. 4.7company rating

    Medtronic Inc. job in Raleigh, NC

    We anticipate the application window for this opening will close on - 18 Jan 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life We are seeking a committed professional to join our team. While this is a remote position not located at a physical Medtronic site, the candidate hired will be required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role. The Medtronic Interstim Sales Representative will manage territory base business and growth by initiating, supporting and developing strategic implanting centers and assisting in developing key referral networks. In certain geographies, they will also have primary responsibility for development of referral networks. Act as primary account/implanter relationship contact for assigned territory's customer needs including account level reimbursement responsibility. Includes coordination of all support activities and development of sales partnerships with distribution alliances. This is a field-based position. We are seeking a committed professional, required to reside within the territory and drive to multiple accounts throughout the region, to join our winning team. A valid driver's license is essential for this role, which also includes travel outside the territory, presenting opportunities for broader engagement. Responsibilities may include the following and other duties may be assigned: * Selling Interstim devices for specific therapies to physicians, institutions, payors, and other appropriate medical staff * Partnering with strategic implanting centers to develop the account/implanter practice through; * Providing product and therapy technical support and service * Including consultation of strategic management and analysis of trends * Utilization of appropriate Neuro business partners to present marketing and business plans to accounts for territory development and growth * Other activities as they arise, as assigned buy the sales leadership. We seek out and hire a diverse workforce at every level: We need fresh ideas and inclusive insights to continue to be an innovative industry leader -that's why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients. To learn more about Inclusion & Diversity at Medtronic Click Here Qualifications Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident on your resume. * High School Diploma (or equivalent) AND 6+ years of experience* * OR Associate's Degree AND 4+ years of experience* * OR Bachelor's Degree AND 2+ years of experience* * Relevant sales, clinical, or related experience in medical devices, medtech, healthcare, or life sciences Nice to Have: * Solid knowledge of the Reimbursement climate * Experience calling on physicians in one or more of the following or related referral accounts * Neurology, Urology, Colo Rectal Surgeons * Experience in developing new, innovative markets; * Experience in making multiple referral calls on a daily basis * Familiarity with the O.R. * Solid job skills in business planning/consulting and territory financial analysis; preferred knowledge of managed care * Experience with Physiology/clinical therapies * Experience with Implantable devices * Excellent interpersonal, communication, negotiation skills * Team oriented * Conceptual/consultative sales skills * Understanding of all quality policy/system items that are applicable * Ability to follow all work/quality procedures to ensure quality system compliance and high quality work Preference will be given to local qualified candidates and candidates with Medtronic experience Additional Job Requirements: Frequent required travel to customer clinics, hospitals and off-site meetings. The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. The physical demands described within the Responsibilities section of this are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America). Must have a valid driver's license and active vehicle insurance policy. In addition, your driving record will be reviewed and will be considered as part of your application. Must be able to drive approximately 50% of the time within assigned territory and may require overnight travel. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here. Business Description: Pelvic Health is part of the Neuroscience Portfolio. Our therapies treat patients suffering from overactive bladder, non-obstructive urinary retention and fecal incontinence with our sacral neuromodulation (SNM) systems InterStim X️ and InterStim️ Micro; and our percutaneous tibial neuromodulation (PTNM) system NURO️. More than 400 million people worldwide have incontinence, and many of them limit their lives socially, professionally and personally because of their condition. Our goal is to expand access to our therapies so we can help potentially millions of people get their lives back. Click here to learn more about products. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$65,000.00 - $65,000.00 The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. Learn more about total rewards here. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
    $65k-65k yearly Auto-Apply 3d ago

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