Manager, CSV Cell Therapy
Bristol Myers Squibb
August 13, 2026
Remote friendly (Summit, NJ)
United States
IT
Position Summary
The Manager, CSV Cell Therapy supports implementation and support of manufacturing/laboratory equipment and computerized systems at multi-use sites. With minimum supervision, performs routine tasks and uses strong analytical skills to recognize and solve common problems. Hands-on leadership responsible for individual and team-based efforts, projects, and tasks; fosters a productive learning environment and ensures timely completion.
Duties/Responsibilities
- Support equipment qualification and validation; investigate and resolve Deviations, CAPA, and other issues.
- Configure/document computerized system configurations to meet CFR 21 Part 11.
- Execute qualification/validation protocols; supervise vendors for qualification functions.
- Ensure qualification/validation documentation accuracy, completeness, and compliance.
- Own lifecycle deliverables for qualification of equipment and CSV for single/multi-user computerized systems.
- Develop deliverables: Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.
- Manage projects of moderate scope; supervise team; manage projects of varying scope; maintain positive relationships with team members and site customers.
- Author quality procedures/training documents; deliver training to departmental personnel and business partners.
- Innovate/develop tools for more efficient and compliant solutions; support equipment implementation (scheduling, procurement, site prep, installation, qualification, turnover).
- Support standardization efforts in review/approval of validation deliverables.
- Provide customer service/support: respond to equipment qualification/support requests; provide technical guidance; interface with customers.
- Ensure compliance of equipment/facilities/programs; act as departmental lead/SME in internal and regulatory audits.
Qualifications
- Excellent understanding of cGxP requirements 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 and manufacturing systems; experience executing equipment qualification documents.
- Ability to interact with manufacturing, lab, QA, and Facilities.
- Strong knowledge of MS Windows client/server technologies.
- Strong organization/multi-tasking in fast-paced environments.
- Strong written/verbal communication; technical writing/document development; read/interpret engineering manuals/drawings.
- Strong MS Office skills (Word, Excel, Visio, Outlook).
- BS degree (or equivalent); minimum 5 years in FDA-regulated industry.
Application instructions
None stated in the provided text.
The Manager, CSV Cell Therapy supports implementation and support of manufacturing/laboratory equipment and computerized systems at multi-use sites. With minimum supervision, performs routine tasks and uses strong analytical skills to recognize and solve common problems. Hands-on leadership responsible for individual and team-based efforts, projects, and tasks; fosters a productive learning environment and ensures timely completion.
Duties/Responsibilities
- Support equipment qualification and validation; investigate and resolve Deviations, CAPA, and other issues.
- Configure/document computerized system configurations to meet CFR 21 Part 11.
- Execute qualification/validation protocols; supervise vendors for qualification functions.
- Ensure qualification/validation documentation accuracy, completeness, and compliance.
- Own lifecycle deliverables for qualification of equipment and CSV for single/multi-user computerized systems.
- Develop deliverables: Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.
- Manage projects of moderate scope; supervise team; manage projects of varying scope; maintain positive relationships with team members and site customers.
- Author quality procedures/training documents; deliver training to departmental personnel and business partners.
- Innovate/develop tools for more efficient and compliant solutions; support equipment implementation (scheduling, procurement, site prep, installation, qualification, turnover).
- Support standardization efforts in review/approval of validation deliverables.
- Provide customer service/support: respond to equipment qualification/support requests; provide technical guidance; interface with customers.
- Ensure compliance of equipment/facilities/programs; act as departmental lead/SME in internal and regulatory audits.
Qualifications
- Excellent understanding of cGxP requirements 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 and manufacturing systems; experience executing equipment qualification documents.
- Ability to interact with manufacturing, lab, QA, and Facilities.
- Strong knowledge of MS Windows client/server technologies.
- Strong organization/multi-tasking in fast-paced environments.
- Strong written/verbal communication; technical writing/document development; read/interpret engineering manuals/drawings.
- Strong MS Office skills (Word, Excel, Visio, Outlook).
- BS degree (or equivalent); minimum 5 years in FDA-regulated industry.
Application instructions
None stated in the provided text.