Cell Therapy CSV Lead & Validation Manager

Bristol Myers Squibb EU Policy; South Hadley Falls (MA); On-site; USD 107,000 - 129,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k)

Paid Time Off

Job summary

Bristol Myers Squibb is seeking a Manager, CSV Cell Therapy to oversee qualification and validation activities for manufacturing and laboratory equipment and computerized systems across multi-use sites. The role requires hands-on leadership, cross-functional collaboration, and ensuring compliance with CFR Part 11 and cGXP.

Responsibilities include managing system qualifications, CAPA investigations, developing validation deliverables, and coordinating with vendors.

Qualifications

• Excellent understanding of cGXP requirements and good documentation practices in pharma.
• Strong knowledge of ISPE guidance and 21 CFR Part 11 compliance.
• Solid understanding of SDLC principles and standards.
• Ability to work with end users to document requirements.
• Experience with pharmaceutical lab and manufacturing systems.
• Experience executing equipment qualification documents.

Responsibilities

• Maintain qualified and validated equipment and systems per policies and procedures.
• Lead qualification/validation activities and document deliverables.
• Manage vendor qualifications and validation documentation.
• Own lifecycle deliverables for equipment qualification and CSV for computerized systems.
• Develop validation plans, requirements specs, validation protocols, and traceability matrices.

Skills

cGXP knowledge

21 CFR Part 11

SDLC

Documentation

Project management

Vendor management

Cross-functional collaboration

MS Windows

MS Office

Education

BS degree or equivalent experience

Tools

MS Windows

MS Office

Job description

Bristol Myers Squibb is seeking a Manager, CSV Cell Therapy to oversee qualification and validation activities for manufacturing and laboratory equipment and computerized systems across multi-use sites. The role requires hands-on leadership, cross-functional collaboration, and ensuring compliance with CFR Part 11 and cGXP.

Responsibilities include managing system qualifications, CAPA investigations, developing validation deliverables, and coordinating with vendors.