Manager, CSV Cell Therapy
Bristol Myers Squibb
July 01, 2026
Remote friendly (Summit, NJ)
United States
IT
Position Summary
Manager, CSV Cell Therapy supports implementation and support of manufacturing/laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers.
Duties/Responsibilities
- Support equipment qualification and validation activities.
- Investigate and resolve Deviations and CAPA investigations.
- Configure and document computerized systems to meet CFR21 Part 11 requirements.
- Execute equipment qualification and validation protocols.
- Supervise vendors for qualification functions.
- Complete qualification/validation documentation with accuracy and compliance to Celgene standards.
- Own lifecycle deliverables for equipment qualification and CSV for single and multi-user computerized systems.
- Develop validation/qualification deliverables (e.g., Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls).
- Initiate/manage projects of moderate scope and varying complexity; supervise/direct team members.
- Author quality procedures and training documents; deliver training and best practices.
- Innovate and develop tools/solutions for more efficient and compliant outcomes.
- Support equipment implementation (scheduling, procurement, site prep, installation, qualification, turnover).
- Support standardization of review/approval of validation deliverables.
- Provide customer service/support; respond to qualification/support requests; provide technical guidance.
- Ensure compliance of equipment/facilities/programs; act as departmental lead/SME in audits.
Qualifications / Skills
- Excellent understanding of cGXP and documentation practices.
- Strong knowledge of ISPE guidance and 21 CFR Part 11; SDLC principles.
- Ability to identify/document user and functional requirements.
- Knowledge of pharmaceutical lab/manufacturing systems; experience executing equipment qualification documents.
- Ability to interface with manufacturing, lab, QA, Facilities.
- Proficient MS Windows client/server; Microsoft Office (Word, Excel, Visio, Outlook); technical writing.
- Strong communication, organization, multi-tasking, and troubleshooting skills.
Education/Experience
- BS degree (or equivalent experience).
- Minimum 5 years in FDA-regulated industry.
Benefits
- Health coverage (medical, pharmacy, dental, vision).
- Wellbeing support (programs/EAP).
- 401(k), disability and life insurance, and other listed protection benefits.
- Paid time off (flexible time off for US Exempt; vacation/holidays for other listed groups).
Manager, CSV Cell Therapy supports implementation and support of manufacturing/laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers.
Duties/Responsibilities
- Support equipment qualification and validation activities.
- Investigate and resolve Deviations and CAPA investigations.
- Configure and document computerized systems to meet CFR21 Part 11 requirements.
- Execute equipment qualification and validation protocols.
- Supervise vendors for qualification functions.
- Complete qualification/validation documentation with accuracy and compliance to Celgene standards.
- Own lifecycle deliverables for equipment qualification and CSV for single and multi-user computerized systems.
- Develop validation/qualification deliverables (e.g., Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls).
- Initiate/manage projects of moderate scope and varying complexity; supervise/direct team members.
- Author quality procedures and training documents; deliver training and best practices.
- Innovate and develop tools/solutions for more efficient and compliant outcomes.
- Support equipment implementation (scheduling, procurement, site prep, installation, qualification, turnover).
- Support standardization of review/approval of validation deliverables.
- Provide customer service/support; respond to qualification/support requests; provide technical guidance.
- Ensure compliance of equipment/facilities/programs; act as departmental lead/SME in audits.
Qualifications / Skills
- Excellent understanding of cGXP and documentation practices.
- Strong knowledge of ISPE guidance and 21 CFR Part 11; SDLC principles.
- Ability to identify/document user and functional requirements.
- Knowledge of pharmaceutical lab/manufacturing systems; experience executing equipment qualification documents.
- Ability to interface with manufacturing, lab, QA, Facilities.
- Proficient MS Windows client/server; Microsoft Office (Word, Excel, Visio, Outlook); technical writing.
- Strong communication, organization, multi-tasking, and troubleshooting skills.
Education/Experience
- BS degree (or equivalent experience).
- Minimum 5 years in FDA-regulated industry.
Benefits
- Health coverage (medical, pharmacy, dental, vision).
- Wellbeing support (programs/EAP).
- 401(k), disability and life insurance, and other listed protection benefits.
- Paid time off (flexible time off for US Exempt; vacation/holidays for other listed groups).