Manager, Computer System Validation (CSV) – Cell Therapy

Bristol Myers Squibb • Summit, NJ

3d • $106,630 - $129,214

About The Position

The Manager, CSV Cell Therapy supports implementation and ongoing support of manufacturing and laboratory equipment and computerized systems at multi-use sites, working with internal customers and external service providers. With general direction and minimal supervision, the role performs routine work, applies analytical skills to resolve problems, and collaborates with colleagues and stakeholders to achieve team goals. Through hands-on leadership, the manager is responsible for individual and team efforts, projects, and other tasks, while promoting a productive learning environment and timely completion of work.

The position maintains qualified and validated equipment and systems in compliance with policies, guidelines, and procedures. It leads qualification and validation lifecycle work for equipment and computerized systems, including single- and multi-user systems, and supports equipment and system implementation projects from scheduling and procurement through site preparation, installation, qualification, and handover. The manager also provides customer support, technical guidance, training, and leadership in regulatory audits.

Requirements

• Bachelor of Science degree or equivalent experience.
• At least 5 years of experience in an FDA-regulated industry.
• Excellent understanding of cGXP requirements and good documentation practices for pharmaceutical systems, equipment, and instrumentation.
• Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.
• Strong working knowledge of SDLC principles and standards.
• Ability to work with end users to identify and document user and functional requirements.
• Knowledge of pharmaceutical laboratory and manufacturing systems.
• Experience executing equipment qualification documents.
• Ability to interact effectively with manufacturing, laboratory, QA, and Facilities groups.
• Strong working knowledge of Microsoft Windows client and server technologies.
• Ability to organize work in a fast-paced environment, monitor dependencies affecting timely completion, and manage multiple tasks simultaneously.
• Strong written, verbal, and presentation skills, including writing clear emails and reports and developing technical documents.
• Ability to follow oral and written instructions and read and interpret relevant engineering manuals and drawings.
• Ability to communicate effectively with employees, contractors, and vendors.
• Strong Microsoft Office skills, including Word, Excel, Visio, and Outlook, and ability to learn software used for equipment qualification.
• Ability to perform occasional stooping, bending, stretching, pushing, pulling, reaching, and lifting up to 25 pounds; sit, stand, walk, and move within the workspace for extended periods; and perform repetitive hand and finger tasks.
• Ability to work safely and effectively alone or with others.

Responsibilities

• Support equipment qualification and validation activities, including execution of qualification and validation protocols.
• Investigate and resolve deviations, CAPA investigations, and other potential issues.
• Configure computerized systems and document configurations to meet 21 CFR Part 11 requirements.
• Supervise vendors performing qualification functions.
• Complete qualification and validation documentation accurately, completely, and in compliance with company standards.
• Own qualification lifecycle deliverables for equipment and full CSV lifecycle deliverables for single- and multi-user computerized systems.
• Develop validation and qualification deliverables, including validation plans, requirements specifications, validation protocols, traceability matrices, summary reports, and change controls.
• Initiate, manage, and lead projects of moderate scope and complexity within the functional area.
• Supervise and direct team members to ensure objectives are completed.
• Maintain positive working relationships with team members and site customers and promote a positive learning and team environment.
• Author quality procedures and training documents, and deliver training on procedures and best practices to departmental personnel and business partners.
• Research and develop tools and solutions that improve departmental efficiency and compliance.
• Support laboratory and manufacturing equipment implementation projects, including scheduling, procurement, site preparation, installation, qualification, and handover to the business area.
• Support standardization efforts in the review and approval of validation deliverables.
• Review, prioritize, and promptly respond to customer equipment qualification and support requests.
• Provide technical support and guidance on validation, quality processes, and equipment qualification, and work with customers to ensure expectations are met.
• Ensure equipment, facilities, and programs remain compliant.
• Act as departmental lead and subject matter expert during internal and regulatory audits.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Flexible Time Off without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• 160 hours of annual paid vacation for eligible new non-exempt employees, RayzeBio employees, and employees located in Puerto Rico, subject to manager approval.
• 11 paid company holidays annually.
• Three optional holidays for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for additional discretionary cash incentives and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager