Manager, Computer System Validation Cell Therapy

Company: Bristol-Myers Squibb
Location: Summit
Posted on: May 24, 2025

Job Description:

Manager, Computer System Validation Cell Therapy page is loadedManager, Computer System Validation Cell TherapyApply locations Summit West - NJ - US time type Full time posted on Posted 3 Days Ago job requisition id R1591930Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .Manager, Computer System Validation Cell Therapy, Bristol-Myers Squibb Company, Summit, NJ. Develop, review, and approve protocols and associated reports while adhering to a change management process by drawing on experience with, MS Windows client and server technologies, standard networking principles and technologies, current good practices (cGXP) requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry, International Society for Pharmaceutical Engineering (ISPE) guidance, 21 CFR Part 11 compliance, identifying and documenting user and functional requirements, and executing equipment qualification documents. Support the execution of equipment qualifications and validation protocols; support calibration, equipment qualification and validation activities; configure and document the configuration of computerized systems; develop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls; provide direct oversight of CSV personnel providing hands-on leadership; support the continuous improvement of the Commissioning, Qualification and Validation (CQV) program; support laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area; own all lifecycle deliverables in the qualification of equipment and full CSV for single and multi-user computerized systems; review, prioritize, and respond to customer equipment qualification and support requests; provide technical support and guidance on calibration and equipment qualification issues, investigations, deviations and CAPA actions.40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. $166,000/yr - $203,030/yr.MINIMUM REQUIREMENTS :Bachelor's degree or foreign equivalent degree in Engineering, or a related field, and five (5) years of post-baccalaureate, progressive experience.Must have experience with/in:

• MS Windows client and server technologies;
• Standard networking principles and technologies;
• Current good practices (cGXP) requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry;
• International Society for Pharmaceutical Engineering (ISPE) guidance;
• 21 CFR Part 11 compliance;
• Identifying and documenting user and functional requirements; and
• Executing equipment qualification documents.The required skills do not need to be maintained over the full term of required experience.May work remotely five (5) days every two (2) weeks within normal commuting distance of Summit, NJ.The starting compensation for this job is a range from $166,000/yr - $203,030/yr, plus incentive cash and stock opportunities (based on eligibility).The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.*** If BMS Careers Site link is not copying and pasting correctly, please add manually using the following address: https://jobs.bms.com/careers/join .If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing Careers
  With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.W e're creatinginnovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
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