Psc Biotech jobs in Los Angeles, CA

Job Description PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech , it's about more than just a job-it's about your career and your future. Your Role CQV Engineers are responsible for supporting commissioning, qualification, and validation projects for pharmaceutical facilities, utilities, equipment, and systems. You will play a key role in executing CQV deliverables and ensuring operational readiness from the ground up to support our clients' success. Assist in commissioning and startup of new equipment, utilities, and cleanroom systems during facility buildout. Develop and execute IQ/OQ/PQ protocols for newly installed systems and equipment. Prepare and maintain documentation, including validation protocols, plans, reports, and standard operating procedures. Support risk assessments and mitigation strategies related to CQV activities. Troubleshoot and assist in resolving issues related to equipment and process performance. Collaborate with cross-functional teams to align CQV activities with construction and project timelines. Coordinate with vendors and contractors to support hand-offs and system turnover. Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.). Provide technical support during validation execution and qualification activities. Additional responsibilities as required. Requirements Bachelor's degree in engineering or a related field. 7-10 years of commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries. Proven experience supporting or leading CQV activities during new facility buildouts, including equipment installation and startup. Strong background in cleanroom facilities, process equipment, and utility systems. Familiarity with project execution and project management tools. Deep understanding of regulatory requirements and industry standards (GMP, GAMP, FDA, EMA). Knowledge of validation lifecycle and risk-based approaches. Excellent analytical and technical problem-solving skills. Strong technical writing skills and experience with validation documentation (protocols, reports, procedures, etc.). Effective communication and interpersonal skills. Organized, proactive, and detail-oriented with a commitment to quality and compliance. At PSC Biotech, many of our projects and clients are located in various regions around the country. We value candidates who are willing and able to travel as needed for project assignments and client engagements. Adaptability to different locations, cultures, and work environments is essential for successful collaboration. Must be authorized to work in the US. No C2C at this time. Benefits Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy. Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more. 401(k) and 401(k) matching PTO, Sick Time, and Paid Holidays Education Assistance Pet Insurance Discounted rate at Anytime Fitness Financial Perks and Discounts Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $90,000 - $120,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-RD1

** A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. **The Opportunity** The Director, Integrated Enablement & Engagement Process Lead (EPL) is a critical member of the Field Medical team, collaborating with the US Medical Digital team. This individual is instrumental in defining, aligning, and embedding digital, data, and analytics capabilities to not only meet current business needs but also proactively address and anticipate future needs. Acting as a key connector and central liaison between Field Medical and product teams, this role provides strong user understanding, workflow expertise, and product ecosystem knowledge to effectively embed tools within a complex, matrixed organization. Simultaneously, this role coordinates directly with users to drive successful user adoption of new digital capabilities and initiatives. This role plays a strategic part in identifying business needs, shaping product direction and prioritization, and integrating products into new and existing workflows to maximize impact in Field Medical. Furthermore, this role drives the planning and execution of change management, knowledge sharing, training, and adoption, as well as understanding and measurement activities, in partnership with Operational Excellence teams. This role requires a deep understanding of Field Medical priorities, standards of excellence, compliance, and the ability to intuitively manage, inspire, and build trust within a matrixed organization. **Key Responsibilities** + Strategic Liaison & Stakeholder Engagement: Serves as the primary point of contact for Field Medical capability needs, collaborating with cross-functional stakeholders to identify, synthesize, and prioritize user feedback, and ensuring end-to-end excellence across Field Medical digital and AI initiatives. + Workflow Design & Process Integration: Accountable for seamless integration of new digital products into workflows, serving as a subject matter expert to identify capabilities, validate requirements, and lead process changes to optimize workflows. + Enablement & Support: Develops and implements strategies to drive awareness and adoption of new tools, champions change management, and designs and delivers comprehensive training. + Change Leadership & Continuous Improvement: Leads complex change initiatives, drives organizational change from current to future state, and continuously partners with stakeholders to ensure alignment on priorities. + Measurement & Optimization: Regularly assesses and reports on the health of Field Medical operations, collaborates with partners to establish KPIs, and synthesizes measurement insights and user feedback into actionable learnings. + Compliance & Governance: Establishes robust project governance frameworks, ensures adherence to regulatory compliance and privacy standards, and builds relationships with legal and compliance partners. **Who you are** **Qualifications & Experience** + Bachelor's degree + A minimum of 8 years of work experience, with at least 6 years of experience in the pharmaceutical or biotech industry, including 2 years in Healthcare Business Analytics. + Experience in machine learning, deep learning, AI techniques, and building impactful data visualizations for medical decision-making (e.g., using Spotfire , Tableau, and RShiny). Strong data proficiency with a deep understanding of data strategy, technology, and platforms. + Strong ability to work across functions in matrixed environments, providing strategic guidance, engaging stakeholders on data and visualization needs, and influencing senior leadership without direct authority. + Experience with sole ownership of tactics or pieces, ability to articulate business problems, identify solutions, and own content development from strategy through execution. Demonstrated experience with strategic planning, prioritizing, and management of high-level initiatives and projects. + Strong understanding of the healthcare landscape and customer types (health systems, payers, providers, HCPs, patients, IDNs, distributors, pathways), and how they operate their businesses. **Preferred Qualifications & Experience** + MBA or other related graduate-level degree + 5+ years of experience in clinical development with strong skills in clinical trial data analysis, RWD assets. + Six sigma, PMP, or similar certifications + Proven ability to embed products, embrace agile methodologies, and effectively organize for impactful outcomes, while continuously investing in personal development. + Demonstrates an enterprise and execution mindset, thriving in ambiguous, transformational environments with adaptive and critical thinking. + Exhibits inspiring, visionary, customer-first leadership, strong business acumen, excellent presentation, interpersonal, and communication skills, alongside highly proficient project planning and oversight. **Location & Travel Requirements** The role is field-based, with a minimum of 30% of the time expected to be spent in the office in South San Francisco, CA, or traveling to locations designated by the Business. The expected salary range for this position based on the primary location of South San Francisco, CA is $136,100 - 252,700. 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 (**************************************************** Relocation benefits are not available for this job posting 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 (***************************************************************************************************** .

We anticipate the application window for this opening will close on - 2 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 LifeAt Medtronic, we seek out and hire a diverse workforce at every level. We need fresh ideas and inclusive insights to continue being an innovative industry leader - that's why we make it a priority to seek, attract, and develop employees who are patient-centric, passionate, and who reflect the same wide range of life experiences as the patients we serve. We are currently seeking a Principal Production Planner (Operations Planner) for our Irvine, CA site. This role sits within the Operations Scheduling organization and plays a critical, strategic role in ensuring supply continuity and operational excellence. The Principal Planner will collaborate extensively with Master Production Scheduling, Supply Network Planning, Engineering, Operations, Quality, Master Data, and external partners. This position is fully on-site, with the expectation that the employee will be on campus for all working days. The ideal candidate has deep expertise in production planning, demonstrates strong leadership without formal authority, and brings thought leadership to drive supply chain improvements. Do meaningful work, make a difference, and improve lives - starting with your own! In this highly visible and influential role, you will drive end-to-end production planning execution and lead initiatives that improve supply health, operational efficiency, and delivery performance. You will own critical processes such as daily/weekly production scheduling, material readiness, new product introduction planning, and scenario analysis in support of key business objectives. You will act as the primary planning expert for your value stream, identify and mitigate risks, influence cross-functional decisions, and provide insights that shape operational strategies. Responsibilities may include but are not limited to: Serve as the primary planning authority for the assigned value stream, providing strategic guidance and expert insights. Own production planning, prioritization, and KPI oversight at a strategic level. Lead inventory management, consumption analysis, and root-cause investigation for variances. Develop and communicate supply health assessments, mitigation plans, and operational recommendations. Conduct scenario planning, capacity analysis, and planning simulations to support business decisions. Represent Operations Scheduling in cross-functional forums, presenting findings, risks, and recommendations. Own and troubleshoot advanced master production scheduling issues within SAP, including master data impacts. Partner with operations and supply chain leadership to define planning strategies that support financial and service goals. Participate in and lead tier meetings, driving clarity and alignment on supply, materials availability, and production priorities. Monitor and report performance metrics; develop insights to improve planning accuracy and operational execution. Coach and provide guidance to less experienced planners (no direct people management required). Must Have: Minimum Requirements Bachelor's degree Minimum of 7 years of relevant experience, OR Advanced degree with a minimum of 5 years of relevant experience Nice to Have Deep experience with MRP/ERP systems (strong preference for SAP or Blue Yonder) Advanced proficiency with Microsoft Office and data analysis tools Strong analytical, quantitative, and data-driven decision-making skills Excellent written and verbal communication skills; ability to influence peers and leadership Strong organizational skills and mastery of cross-functional collaboration Ability to identify patterns, connect detailed data to strategy, and anticipate upstream/downstream impacts Experience working in a regulated industry (medical device or pharmaceutical preferred) Understanding of quality systems and good manufacturing practices APICS CPIM/CSCP or other supply chain certifications Understanding of cost accounting principles Knowledge of supply, services, or confidentiality contracts Lean/Six Sigma Green Belt (or comparable continuous improvement training) 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):$92,800.00 - $139,200.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).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). 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 anticipate the application window for this opening will close on - 21 Dec 2025 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. Collaborates with key stakeholders to coordinate, develop and execute clinical strategies to achieve short- and long-term business objectives within region as it relates ablation solutions activities and program. Drive execution of key CAS initiatives to achieve Group, OU and Regional level goals. Maximize regional personnel performance by managing, developing and motivating clinical support employees to deliver unsurpassed patient care, physician/AHP support and technical expertise in the hospital, and other care settings. This position will require up to 50% travel within their dedicated territory Primary Responsibilities Clinical Support Leadership Lead all regional clinical support related activities and programs to efficiently optimize resources, deliver customer value and deliver exceptional clinical guidance Partners with sales team to drive key clinical support initiatives and provide assessments via periodic business reviews that highlight the value of Medtronic ablation clinical support to our customers Work with regional leadership to align resources based on business priorities and appropriate clinical support demands Lead and drive changes focused on strengthening of EP acumen, prioritization of understanding and implementation of expanded EP ablation solutions to the customer, and customer engagement Collaborate with sales team and additional key stakeholders to coordinate and execute strategies to achieve ablation solution expansion business objectives People Management Provide ongoing feedback and coaching to direct reports; provides regular performance reviews and implements corrective actions where necessary. Leads regional Clinical Specialists to execute on key goals and objectives Assist employees with goal setting, performance reviews, and individual development planning (IDP's). Responsible Clinical Specialist recruiting and hiring. Continually work to maintain a strong, diverse bench of Clinical Specialist talent for future hiring opportunities. Sales Support Understands national, regional and territory sales objectives. Works in partnership with account managers and CAS Regional Manager to achieve/ exceed goals Serves as effective Medtronic CAS representative to physicians and support staff regarding Medtronic CAS products, service and support Promotes the safe and effective use of Medtronic CAS products and related procedures. Business Operations Business Discipline: Sales support, MPX reports, credentialing, expense management, data privacy, warranty credits Ensure efficient, effective use of inventory, expenses and assets Technical Support/ Clinical Support Represents Medtronic CAS during ablations procedures to provide clinical guidance, technical assistance, and customer engagement Receives technical inquiries by customers and team. Researches and supports resolution for solutions to questions or problems Educational Support Partner with education team and internal resources to facilitate and lead the training of new and tenured field personnel Educates and trains physicians, hospital personnel and office staff on CAS products and procedures. (e.g. one-on-one training sessions, in-service education programs, seminars and/or outside symposiums) Supports and provides training and resources for hospital staff to enable them to conduct training for their personnel Required Qualifications Bachelor's Degree with 5 years of relevant experience or advanced degree with 3 years of relevant experience. Preferred Qualifications Experience within Electrophysiology (sales, clinical, etc.) Management experience (sales, clinical, training, etc.) 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 - $150,000The 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 anticipate the application window for this opening will close on - 19 Dec 2025 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 LifeIf you are inspired by innovation and business strategy, strive for outstanding collaboration, and have a strong inner-drive and excellent communication skills, come join our team! Be the catalyst for growth and transformation in Cardiac Surgery and live the Medtronic Mission: To contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life. In Cardiac Surgery, we are committed to advancing and delivering optimal cardiac surgical care. The clinical specialist will support field sales activities in the ECT/ECLS product line, being the field expert for these products and associated procedures. This is a Hybrid role in which the clinical specialist will have sales accountability and clinical knowledge expectations. Primary responsibilities include supporting the Cardiac Surgery business in areas of surgical case coverage, support, troubleshooting and clinician education and training. A Day in the Life - ECT/ECLS Clinical Specialist Develop and deliver both live and virtual training programs on Extracorporeal Membrane Oxygenation (ECMO) products to healthcare providers in hospitals and medical facilities Collaborate with the sales and marketing teams to ensure training materials are aligned with product messaging and sales objectives Conduct product demonstrations and training sessions for healthcare providers on the safe and effective use of ECT/ECMO products Provide guidance and support to healthcare providers on the selection, setup, and management of ECT/ECMO products Be proficient in understanding Cardiac Fluoroscopic imaging for proper placement of Life Support Cannula/Catheter Work closely with key opinion leaders and industry experts to stay up-to-date on the latest trends and best practices related to ECMO therapy Collect feedback and evaluations from healthcare providers on training programs and materials, and use this feedback to continuously improve training offerings Collaborate with the sales team to identify opportunities for additional training and support to drive product adoption and sales Participate in trade shows and other industry events to promote ECMO products and training programs Provide technical and administrative support to healthcare providers for research endeavors that advance ECMO products including acting as an ERP liaison for internally supported research Blood Management - In-service and train hospital personnel on how to run autotransfusion devices (auto Log IQ) and anticoagulation management devices (HMS Plus) in the perioperative setting (operating rooms, recovery rooms, Cath Labs, CVICU, ICU, etc.). This includes product evaluations, validations, and installations Available to teach the principles of autotransfusion, anticoagulation management, and perioperative blood management at hospitals, regional medical meetings, national and international medical meetings, perfusion schools, and anesthesia technologist schools Participate in the development and design of new autotransfusion and anticoagulation management devices providing input as a clinical/technical expert Participate in new sales representative and new employee product training as needed Assist Medtronic Lifeline, Technical Support, and Customer Focused Quality teams with customer clinical/technical questions and product complaints Monitor competitive moves as they relate to the Blood Management products Assess and Update POC training tools when needed Interact with Point of Care Medical Laboratory technicians and assist in diagnostic device qualifications as needed Other Responsibilities Identify and champion new and creative approaches to business, operations and marketing opportunities and challenges Attend and support key regional, national, and international medical meetings, e.g., ELSO, SEECMO, ISHLT, AmSECT, CREF etc. Participate in Voice of Customer (VOC) and customer VIP sessions Assist marketing in portfolio management and promotional plans designed to increase penetration for existing, enhanced and new products Proficient with using ECMO simulation tools ( iSimulate, Smart simulator, Chamberlain station, silicone model, InvoMEL) to support simulation events Qualifications - External BASIC QUALIFICATIONS: IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME Bachelor's degree and at least 4+ years of medical sales, ECLS clinical specialist, or 2 years clinical ECMO experience Certified Clinical Perfusionist, Respiratory Therapist or RN with ECMO experience ECLS/ECMO experience - minimum of 2 years Ability to communicate effectively with marketing, sales and healthcare professionals Knowledge of blood physiology and Blood Management products used in clinical settings Ability to travel extensively - up to 80% of time DESIRED/PREFERRED QUALIFICATIONS (optional): MBA Experience in medical device sales or a clinical specialist role POC customer experience Strong technical aptitude, specifically in Cardiac Surgery and/or the clinical environment Sales orientation or exposure to working with a high performing salesforce Demonstrated ability to develop and implement marketing plans across product lines and customer types Physical Requirements Ability to lift and carry 50 pounds Ability to sit or stand for 6-8 hours per day 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):140000) U.S. Pay Transparency (for SIP, Commission, Hourly Direct, Interns, Executives) 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). 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.

Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Bio-Rad products currently CE Marked under the IVD Directive. Activities include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional notifications, and other related activities. How You'll Make An Impact: * Support the IVDR project by revising the assigned technical files. Each technical file must be generated using the latest technical file template and it must clearly present the product, its characteristics and its expected performance to easily and fully understand the evidence of conformity. Each technical file must include the latest version of the required technical reports, validations, test reports and other documents listed in the technical file table of contents which are an integral part of the technical file. Each assigned technical file must be completed within a pre-defined timeline. Must attend multiple weekly meetings which are intended to help address issues or questions regarding the technical files and keep the project manager informed on the progress of the work. * Support the IVDR labeling conversion project which requires cross-functional participation and weekly group meetings to follow the conversion plan. Update the labeling conversion tracking log based on the monthly manufacturing schedule,the product fill dates, the associated product lot numbers and change requests numbers. As needed, update labeling specifications to meet the IVDR requirements. * Support the tasks to un-CE Mark selected products and track the work until the final labeling reflects the desired changes based on the labeling specification document. * Other miscellaneous activities will include updating the technical file tracking log, notifying and tracking RA Regional notifications of labeling changes, and notifying the RA SAP restriction coordinator when specific product lots need to be restricted to prevent distribution of the product in specific areas of the world. What You Bring: * Requires a Bachelor's degree in biochemistry, biology, medical technology or related fields * 3-5 years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the IVD industry. * Knowledge of FDA, and CE marking requirements for IVD products is a plus * Able to work independently and with others * Communication skills, including negotiation and persuasion. * Analytical, problem solving, computer, and critical thinking skills. * Thorough knowledge of policies, practices and procedures related to RA. Compensation: The estimated hourly range for this position is $45 to $50 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. As a temporary associate, your employment will be managed directly through our approved agency provider. Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see. EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply. Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes. Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it.

Bio-Rad is looking for a Production Chemist I. In the ID Formulation department, you will be responsible for formulating production pools and intermediates. This involves working with a variety of biologicals and chemicals, each with unique properties and characteristics, all while adhering to established GMP processes and procedures. How You'll Make An Impact: * Responsible for bulk formulating diagnostic reagents of medium complexity including custom recipes and intermediates in accordance with approved written procedures and policies. * Leads/trains team members on the manufacturing of low to medium complexity products * Participate in the planning, scheduling and organizing product teams to meet production deadlines. * Responsible for completing production documentation and maintaining quality records to GDP/GMP standards. * Monitors manufacturing processes and performs adjustments when necessary to meet required yields. * Performs Variance review and makes necessary notations for process orders for Supervisors and Finance. * Perform data entry and inventory control utilizing the ERP database. * Must be able to perform production data trending * Supports assigned products and serves as a primary technical resource or subject matter expert for various departments/ groups. * Able to lead/perform Root Cause Analysis, Quality Notification and implement Corrective Actions to improve product quality or process efficiency. * Participates in/leads continuous improvement projects by analyzing and interpreting experimental data using Lean Six Sigma. * Assists with generating new procedures and working closely with R&D and product transfer teams. * Participates in the training and development of new products. * Assists in the building/modifying product recipes and Bill of Materials. What You Bring: * Bachelor's degree in a life science or related field. * 0-3 years working in a general manufacturing environment formulating products in the areas of biological sciences, life sciences, or an equivalent * Experience working in a GMP manufacturing environment preferred. * Must be experienced in using ERP systems- SAP a plus. * Experience leading teams or projects. * Independently leads and coordinates work in a production team and makes decisions of moderate scope. * Understanding of Good Manufacturing Practices and Good Laboratory Practices. * Strong working knowledge of Microsoft Office tools- Excel and Word. * Strong working knowledge of laboratory environment, materials and equipment. Total Rewards Package: At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle. Benefits: We're proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG's), and more! Compensation: The estimated base salary range for this position is $66,560 - $80,800 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is also eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance. Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see. EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply. Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes. Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it. #LI-KD2 Legal Entity: (USA_1000) Bio-Rad Laboratories, Inc.

We anticipate the application window for this opening will close on - 19 Dec 2025 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 The Logistics Director is responsible for designing and managing transportation strategies that ensure the timely, cost-effective, and compliant movement of raw materials and finished goods within a manufacturing supply chain. This role oversees inbound and outbound transportation operations, optimizes carrier networks, and ensures alignment with production schedules to minimize downtime and maintain customer delivery commitments. The Transportation Director collaborates with procurement, production planning, and distribution teams to drive efficiency, reduce costs, and support continuous improvement initiatives across the transportation network. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. Responsibilities may include the following and other duties may be assigned. Core Responsibilities: * Develop and execute transportation strategies that support manufacturing operations, Global intra company material movement and customer delivery requirements. * Manage inbound transportation for raw materials and outbound shipments of finished goods. * Negotiate carrier contracts and monitor performance to ensure cost efficiency and service reliability. * Optimize transportation routes and modes to reduce lead times and support just-in-time manufacturing. * Ensure compliance with DOT, OSHA, and international shipping regulations. * Monitor KPIs such as on-time delivery, freight cost per unit, and carrier performance; implement corrective actions as needed. * Controls the flow of raw and finished goods, services, and information between point of origin through receipt at the manufacturing site, through to customer placement in order to meet customer or manufacturing requirements. * Ensures the execution and continuous improvement of logistics processes, such as the replenishment system, data interchange systems, demand management, electronic data systems administration, and related functions. * Ensures that customer service and time objectives are achieved within existing financial constraints in order to meet marketing and financial objectives. * Builds relationships with manufacturing, suppliers, and customers through the resolution of delivery issues. * Integrates market intelligence from operating entities, distribution, transportation, suppliers, and customers to continuously improve competitive position. Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. Bachelor's degree in Supply Chain, Logistics, Business, or related field (Master's preferred) and 10+ years of transportation or logistics leadership experience in a manufacturing and distribution environments. OR Advanced degree in Supply Chain, Logistics, Business, or related field (Master's preferred) and 7+ years of transportation or logistics leadership experience in a manufacturing and distribution environments. Nice to Have * 10+ years experience transportation leadership in medical device manufacturing or distribution * Strong knowledge of domestic and international transportation regulations. * Proven ability to manage budgets and negotiate carrier contracts. * Excellent leadership, communication, and analytical skills. 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):$153,600.00 - $230,400.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). This position is eligible for an annual long-term incentive plan. 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.

** 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 (***************************************************************************************************** .

We anticipate the application window for this opening will close on - 23 Dec 2025 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 LifeThe Information Security Governance, Risk & Compliance (GRC) Director is responsible for leading and maturing the company's global security governance framework, enterprise cyber risk management program, and compliance activities across IT, OT, cloud, and regulated medical device environments. This leader ensures alignment with cybersecurity expectations, Quality System requirements, and industry best practices. The Director partners closely with IT, R&D, Operations, Legal/Privacy, Quality & Regulatory (QARA), and Internal Audit to strengthen the company's security posture, reduce enterprise risk, and ensure readiness for audits, inspections, and regulatory submissions. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. Responsibilities may include the following and other duties may be assigned. Governance & Security Program Management Develop, manage, and continuously improve the Information Security Governance framework based on NIST 800-53, ISO 27001, and corporate risk objectives. Establish and maintain enterprise security policies, standards, and procedures in coordination with QARA, Legal, and IT. Lead the security steering committees and reporting for executive leadership and board-level governance. Enterprise Cyber Risk Management Own the global cyber risk management strategy, including frameworks, methodologies, risk assessments, and reporting. Partner with business units, manufacturing sites, and R&D to identify, assess, and mitigate technology and cybersecurity risks. Maintain the enterprise cyber risk register and report key risks, KRIs, and risk treatment plans to the CISO and leadership. Lead risk assessments for new products, vendors, technologies, and manufacturing systems. Regulatory & Compliance Oversight Ensure ongoing compliance with SOX NIST 800-53, HIPAA, and global data protection laws. Lead cybersecurity components of internal audits and third-party assessments. Manage alignment with industry frameworks. Controls Assurance & Audit Readiness Build and operate a controls assurance program including internal control testing, continuous monitoring, and audit preparation. Serve as the primary Information Security liaison to Internal Audit and Quality Audit Develop and track remediation plans for audit findings, vulnerabilities, and nonconformities. Vendor & Third-Party Security Oversee third-party cybersecurity risk assessments, contract security language, and ongoing monitoring of suppliers, including global manufacturing partners. Work with Procurement and Legal to ensure supply chain cyber requirements are enforced. Team Leadership & Cross-Functional Collaboration Lead, mentor, and develop a high-performing GRC team (policy, risk, audit, compliance, privacy alignment). Communicate cyber risks and compliance status to executives in a clear, business-focused manner. Required Knowledge and Experience: Requires a Bachelors degree and minimum of 10 years of relevant experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant experience with 7+ years of managerial experience. Nice to Have: Bachelor's degree in Cybersecurity, Information Technology, Engineering, or related field. 10+ years of experience in information security, with at least 5 years in a GRC leadership role. Deep understanding of NIST 800-53, NIST CSF, ISO 27001, and SOX Experience leading enterprise risk assessments, control testing programs, and audit engagements. Demonstrated success building and managing high-performance teams. Excellent communication skills, including the ability to present complex security topics to executives and regulators. Strong leadership presence and executive communication Strategic and analytical mindset with a risk-based approach Ability to influence cross-functionally in a regulated environment Strong understanding of product, manufacturing, and enterprise cybersecurity Continuous improvement and quality-driven mindset 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):$176,800.00 - $265,200.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).This position is eligible for an annual long-term incentive plan.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). 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.

** 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 Automation 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. Senior Principal Automation Engineer (Department: ITOT/Automation Engineering - Leadership Role) will be responsible for providing automation and instrumentation and controls engineering capabilities and experience to the ITOT / Automation Engineering 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 automation and instrumentation and control systems for process, utility and building systems. Lead automation 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. **What You'll Do** + Provide automation, instrumentation, and control engineering design services for facility projects, including upgrades, capacity expansions, and equipment replacements.. + 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 Engineering 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 or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 8 years experience, or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 7years experience. + Minimum of 8 years applicable automation and/or instrument and control system experience preferably majority in drug product function + 5 years in the pharmaceutical/biotech industry/GMP experience. + 24X7 on call support, participate in an on-call environment to meet business continuity requirements, including weekends and holidays as required. 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. + Knowledge of ISA standards and practices for instrumentation. + Knowledge of PID control theories and techniques. + Knowledge of programmable logic controllers, and associated programming languages (RS Logix Preferred). + Practical knowledge of process automation systems, and associated programming languages (Rockwell and Siemens preferred). + 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 (***************************************************************************************************** .

Make a meaningful difference to patients around the world. Our Legal team works to protect our patients, team members, and innovations with the utmost diligence and care. You'll have the opportunity to work with a dedicated team and build lasting partnerships with stakeholders across our global organization. Your legal knowledge and contributions will help us ensure that we are supporting the needs and interests of the patients we serve. This is an on-site position (on-site minimally 4 days per week). How you'll make an impact: This Director, Global Environmental, Product Stewardship, and Supply Chain Counsel (Edwards title is Director, Corporate Counsel) will play a crucial role in supporting our environmental policies and ensuring compliance with relevant laws and regulations. You will also be responsible for advising on product stewardship initiatives, and overseeing supply chain legal matters. Provide legal guidance on global environmental regulations and compliance to ensure the company's operations adhere to local, national, and international standards. Advise on global product stewardship issues, including safe and sustainable product design, lifecycle management, and responsible disposal. Oversee legal aspects of supply chain management, including trade compliance and risk assessments. Collaborate with cross-functional teams to develop and implement applicable policies. Stay informed on current and emerging laws and trends and proactively address potential legal challenges. Support the company in negotiations, regulatory discussions, and compliance audits. Draft, review, and revise legal documents related to environmental, product stewardship, and supply chain matters What you'll need (required): Juris Doctor or equivalent from an ABA-accredited law school with 8 years experience in environmental regulations, product stewardship, or related field Relevant industry experience (e.g., medical device, pharmaceuticals, etc.) or in highly regulated environments What else we look for (preferred): Experience with materials compliance highly preferred Expertise in international environmental product directives and guidance (REACH, RoHS, EU Battery Regulation, POPs, SCIP) Experience supporting a Global Supply Chain organization Experience with trade compliance Excellent analytical, detail-oriented and information seeking skills Excellent organization and time management skills Excellent written and verbal communication skills and interpersonal relationship skills with ability to drive achievement of objective Strict attention to detail Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization Ability to manage competing priorities in a fast-paced environment Represent leadership on projects within multiple areas, interfacing with project managers, legal team and middle management Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $170,000 to $241,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Bio-Rad is looking for a Production Chemical Dispensary Supervisor to supervise the Lineside/Warehousing Department and oversee a production team that distributes chemical raw materials used to produce liquid reagent products. This position plans and assigns work to direct labor personnel, implements policies and procedures, and recommends improvements in production methods, equipment, operating procedures and working conditions within established delivery, quality, compliance, safety, budget and cost standards. How You'll Make An Impact: * Manages a team of production associates engaged in receiving, staging, put away, cycle count, and scrapping of production chemical inventory. * Work is monitored by the production manager. * Supervises team according to established processes, techniques and policies. * Schedules, assigns and manages the daily activities of a team. * Monitors employee performance and prepares and communicates performance reviews. * Coaches and trains personnel in their duties. * Assists in the development of documentation procedures. * Responsible for meeting key metrics such as production schedules, quality standards, production yields, cost targets. * Monitors processes and makes adjustment to stay within schedule, budgets and established targets. * Participate in a variety of standing meetings. * Communicate priorities, performance results and objectives to team members. * Troubleshoots production issues and escalates as appropriate. * Participate on project teams as needed. * Participate as the Bio-Rad representative for this department before FDA, DEA, CALOSHA, and other regulatory body audits. * Make salary recommendations based upon individual performance. * Interviews and select personnel. What You Bring: * High school diploma, GED or equivalent. * Associate's degree or equivalent experience preferred. * 3-5 years warehousing/logistics experience in a laboratory, instrument or chemical processing environment. * 0-2 years production lead experience is a plus. * Familiarity with assigned products. * Proven analytical, communication, computer and some project management experience. * Basic knowledge of inventory management, demand flow technology, production processes and related technologies. * Relevant certifications or training a plus. * Basic knowledge of regulatory requirements. Total Rewards Package: At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle. Benefits: We're proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG's), and more! Compensation: The estimated base salary range for this position is $68,640 - $92,900 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is also eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance. Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see. EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply. Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes. Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it. #LI-KD2 Legal Entity: (USA_1000) Bio-Rad Laboratories, Inc.

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.

We anticipate the application window for this opening will close on - 17 Dec 2025 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 In this role, you will lead, manage, and coordinate the implementation of SPC initiatives across global manufacturing sites to drive process continuous improvement, enhance patient quality, and meet business goals. This role involves developing and deploying best practices, managing financials, aligning with leadership, and cultivating a culture of process excellence. You will act as a bridge between technical teams, key stakeholders, and business objectives, driving the successful delivery of engineering projects and the SPC deployment program. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role can be based at a number of locations across the US. * Lead Global SPC Deployments Program over multiple sites * Develop and manage program schedules, budgets, and resource allocation, while identifying and mitigating risks and developing and managing back-to-green plans as necessary * Identify and mitigate risks, program organization and priority, and tracking * Lead a cross functional team identify and implement process improvements to enhance program efficiency and effectiveness (identify to create work standardization) * Manage financials and Planisware for SPC program with weekly updates and monthly alignments with leadership * Lead and develop global stakeholder management and communications - effectively and efficiently communicating project status, priorities, risks, and issues to multiple stakeholders, including cross-functional team members, site leadership, and executive management. * Engage global plant leadership, lead leadership reviews with continuous improvement and SPC lens * Identify and manage SPC deployment program critical path and key cross functional handoffs. * Manage and report on SPC Program Capital & Expense and Savings portfolio for multiple sites * Manage changing priorities and project hopper * Planisware project and program financial maintenance * Deploy and promote SPC culture to manufacturing sites * Develop and implement the SPC KPI and tracking system across manufacturing * Develop alignment for process and SPC improvements with stakeholders for individual lines and processes * Lead project implementation from assessment through to procedure production release including equipment installation and validation activities * Lead development of a system-based approach for improving process capability, for sustained site continuous improvement after the project is complete Must Haves Bachelor's Degree and 7+ years of Engineering and Program Management experience OR advanced degree and 5+ years of experience Nice to Have * Strong Project Management Skills: Experience leading and managing large projects in operations/ manufacturing plants * Excellent Communication and Interpersonal Skills: Ability to communicate effectively with diverse teams and stakeholders, both verbally and in writing. * Six Sigma/ Lean Sigma certification * Excellent communication and presentation skills, demonstrated teamwork and a strong internal/external customer focus * Negotiation and influence management skills * Experience in identifying risks and implementing risk mitigations into project plans * Program and Project Management to plan, organize and deliver results with key stakeholders and teams * Leadership and Teamwork Skills: Ability to lead, motivate, and inspire teams to achieve common goals. * Technical Background: A strong understanding of engineering principles and methodologies, preferably with experience in the relevant engineering domain. * Problem-Solving and Analytical Skills: Ability to dig into details, identify and resolve complex technical and project-related issues * Risk Management: Ability to identify, assess, and mitigate potential risks throughout the project lifecycle * Medical device / regulated / FDA environment * Developed and implemented culture change * Excellent organizational skills 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):$168,800.00 - $253,200.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). 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). 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.

Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech , it's about more than just a job-it's about your career and your future. Your Role We are seeking a skilled and proactive Project Manager to lead the successful implementation of software solutions across the organization. This role involves managing project timelines, coordinating cross-functional teams, and ensuring that software deployments meet business requirements, quality standards, and deadlines. Lead end-to-end software implementation projects, from planning through deployment and post-launch support. Develop detailed project plans, including scope, schedule, budget, resources, and risk management strategies. Collaborate with internal stakeholders, vendors, and technical teams to define project requirements and deliverables. Monitor project progress and adjust plans as needed to ensure timely delivery. Facilitate regular status meetings, provide updates to leadership, and manage stakeholder expectations. Identify and mitigate project risks and issues proactively. Ensure proper documentation, training, and change management processes are in place. Evaluate project outcomes and conduct post-implementation reviews to identify areas for improvement. Requirements Bachelor's degree in computer science, Information Systems, Business, or related field. 3-5 years of experience managing software implementation projects. Strong understanding of project management methodologies (Agile, Waterfall, Hybrid). Experience with enterprise software systems (e.g., ERP, CRM, HRIS). Excellent communication, leadership, and organizational skills. Proficiency in project management tools (e.g., MS Project, Jira, Asana). PMP, Scrum Master, or similar certification is a plus. Benefits Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy. Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more. 401(k) and 401(k) matching PTO, Sick Time, and Paid Holidays Education Assistance Pet Insurance Discounted rate at Anytime Fitness Financial Perks and Discounts Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $90,000 to $110,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-RD1

Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Aortic stenosis & aortic regurgitation impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: * Oversee the reengineering and optimization of business processes and systems using Power Platform. Act as a Power Platform Subject Matter Expert and be seen as a Power Platform specialist * Configure and test Power Platform systems (Power Apps, Power Automate) to execute features, integration, and reporting * Evaluate and validate functional business requirements against business needs. Translate the needs of the business into Power Platform and Dataverse solutions * Identify root causes and provide guidance for resolutions for testing and validation of Power Platform processes and systems * Serve as liaison between team members and stakeholders in the area of responsibility. Lead efforts to reengineer and optimize business processes and systems * Provide design and architecture guidance to project teams to execute tactical projects / initiatives * Provide leadership and guidance to business CRM administrators on best practices * Provide platform guidance to team members on CRM and Power Platform solutions * Identify and recommend innovations that significantly enhance efficiency and effectiveness of business processes What you will need (Required): * Bachelor's Degree & a minimum of 8 years of experience in a digital Project Management, Product Management or Customer Success role OR equivalent related experience based on Edwards criteria * A minimum of 3 years hands-on experience with Power Apps (Canvas and Model-driven applications) * A minimum of 3 years experience with Power Automate (Cloud flows, Desktop flows, Business process flows) * A minimum of 2 years experience with Microsoft Dataverse (data modeling, security, business rules) What else we look for (Preferred): * Stay current with latest platform features * Microsoft Power Platform certifications (PL-200, PL-400 preferred) * Proven successful project management skills * Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards * Extensive knowledge in at least discipline (e.g. Power Platform ALM and solution management) * Substantial technical knowledge with expertise in at least one technical language or data management system (e.g. Knowledge of Power BI for embedded analytics within Power Apps) * Extensive knowledge of platform ecosystem and integration points within Power Platform and governance * Represents leadership on sections of projects within a specific area interfacing with project managers and team. Ability to train and mentor team members on Power Platform best practices * Consult in project setting within specific sections of area (Experience integrating Power Platform with Azure services and Microsoft 365) Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $118,000 - $167,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. #LI-Hybrid Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As the Clinical Contracts Analyst, you will negotiate and develop contracts associated with clinical trials, ensure contracts comply with regulations and manage the lifecycle of contracts. This is a hybrid role (office and remote blend). Selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days. . How you'll make an impact: Initiate, draft, redline, and negotiate 3rd party moderately complex clinical related contracts (e.g. legal contract language and budgets) based on substantial knowledge of financial/fair market value, regulatory and clinical requirements while demonstrating clinical knowledge. Recommend new/or revised language for contract templates. Identify risks (e.g. site incentives, legal issues, conflict of interest) and actively engage with management to provide recommendations for mitigation. Provide clinical input on functional contract terms, budgets, and scope of services to secure appropriate approvals in collaboration with key stakeholders (e.g. Clinical Affairs, Legal Compliance, Finance) Analyze need for contract amendments or renewals and make recommendations, and/or negotiate changes, to terms and conditions Identify risk associated with project timelines set by project teams, impacting team's deliverables and timelines, and key stakeholders' workload (e.g., Legal Compliance, legal contracts, legal privacy, and risk management) based on revised timelines. Submit proposed final draft and supporting documentation through Legal Department's RFA system for contract approval and secure appropriate signatures within specified signing authority Identify opportunities for process improvement in collaboration with cross-functional teams; present and implement process improvement plans to management and/or key stakeholders. Other duties as apply What you'll need (Required): Bachelors Degree in related field with 3 years experience of previous related work experience in contract negotiation/ administration and financial tracking/analysis against contracts required, or equivalent work experience based on Edwards criteria Experience in healthcare related clinical contracts What else we look for (preferred): Strong experience drafting, reviewing, and negotiating clinical study contracts, including familiarity with terms and conditions, regulatory compliance, and stakeholder collaboration Previous clinical research/clinical trial experience Contract/paralegal certification Proven expertise in Microsoft Office Suite including Word, PowerPoint, Excel, and SharePoint Moderate knowledge of medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act) Understanding of regulatory requirements (e.g., CFR, GCP) and documents Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects Ability to build stable internal/external working relationships Ability to interact professionally with all organizational levels Strict attention to detail For California, the base pay range for this position is $66,000 to $90,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Job Description PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech , it's about more than just a job-it's about your career and your future. Your Role We are hiring a Senior CQV Project Manager to deliver comprehensive support throughout every stage of the CQV lifecycle. This role offers expert guidance in project planning, strategic development, and execution, employing a risk-based methodology to ensure adherence to regulatory standards and the highest levels of product safety. Lead and manage CQV engineers and contractors throughout project execution. Oversee commissioning and startup of new equipment, utilities, and cleanroom systems. Develop and approve IQ/OQ/PQ protocols for newly installed systems and equipment. Prepare, review, and maintain documentation, including validation protocols, plans, reports, and SOPs. Support risk assessments and mitigation strategies related to CQV activities. Ensure timely execution of PPQ testing and validation deliverables. Coordinate with vendors and contractors to support hand-offs and system turnover. Ensure compliance with regulatory requirements (FDA, EMA) and industry standards (GMP, GAMP). Provide technical oversight during validation execution and qualification activities. Additional responsibilities as required. Requirements Bachelor's degree in Engineering, Life Sciences, or related field. 7-10 years of project management experience in pharmaceutical and/or biotech industries. Proven experience leading CQV activities during new facility build outs, including equipment installation and startup. Strong background in aseptic fill-finish operations, cleanroom facilities, process equipment, and utility systems. Familiarity with project execution and project management tools (MS Project, Smartsheet). Deep understanding of regulatory requirements and industry standards (GMP, GAMP, FDA, EMA). Knowledge of validation lifecycle and risk-based approaches. Excellent analytical and technical problem-solving skills. Strong technical writing skills and experience with validation documentation (protocols, reports, procedures). Effective communication and interpersonal skills. Organized, proactive, and detail-oriented with a commitment to quality and compliance. Must be authorized to work in the U.S No C2C at this time Benefits Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy. Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more. 401(k) and 401(k) matching PTO, Sick Time, and Paid Holidays Education Assistance Pet Insurance Discounted rate at Anytime Fitness Financial Perks and Discounts Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $120,000 - $140,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-TP1