Cell Therapy CSV Lead: Validation & Compliance

Bristol-Myers Squibb Co; Summit (NJ); On-site; USD 107,000 - 129,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k) / Disability & Life Insurance

Paid Time Off

Job summary

Bristol Myers Squibb Co is seeking a Manager, CSV Cell Therapy to lead qualification and validation activities for manufacturing and laboratory equipment at multi-use sites. You will own lifecycle deliverables, drive CFR 21 Part 11 compliance, and supervise vendors while developing validation plans and training staff.

The role requires a BS degree (or equivalent) and 5+ years in FDA-regulated environments, with strong collaboration across manufacturing, QA, and IT teams.

Qualifications

• Excellent understanding of cGXP requirements and good documentation practices in pharma.
• Strong knowledge of 21 CFR Part 11 compliance and SDLC principles.
• Ability to document user/functional requirements and interact with multiple groups.
• Proven track record in FDA-regulated environment with equipment qualification.
• Experience leading validation/qualification deliverables and project teams.

Responsibilities

• Maintains qualified/validated equipment and systems per policies and procedures.
• Investigates deviations, CAPA investigations, and issues.
• Configures and documents computerized system validation in line with CFR 21 Part 11.
• Executes equipment qualification and validation protocols.
• Supervises vendors for qualification functions and ensures quality deliverables.
• Owns lifecycle deliverables for equipment qualification and CSV for multi-user systems.
• Develops validation/qualification plans, specs, protocols, traceability matrices, and reports.
• Leads projects within functional area and mentors team members.
• Delivers training on procedures and best practices.

Skills

cGXP

21 CFR 11

SDLC

Documentation

Cross-functional

Education

BS degree or equivalent experience

Job description

Bristol Myers Squibb Co is seeking a Manager, CSV Cell Therapy to lead qualification and validation activities for manufacturing and laboratory equipment at multi-use sites. You will own lifecycle deliverables, drive CFR 21 Part 11 compliance, and supervise vendors while developing validation plans and training staff.

The role requires a BS degree (or equivalent) and 5+ years in FDA-regulated environments, with strong collaboration across manufacturing, QA, and IT teams.