Senior CSV Cell Therapy Lead

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) plan

Job summary

Bristol Myers Squibb is seeking a Manager, CSV Cell Therapy to lead the qualification and validation of equipment and computerized systems at multi-use sites. You will work with internal customers and external vendors to ensure compliance with cGXP and CFR Part 11, while driving process improvements.

You will develop validation deliverables, train staff, and manage projects within a fast-paced pharmaceutical environment, partnering with manufacturing, QA and regulatory teams.

Qualifications

• BS degree or equivalent engineering/science field.
• Minimum 5 years of experience in FDA-regulated industry.
• Excellent understanding of cGXP and good documentation practices.
• Strong knowledge of 21 CFR Part 11 and ISPE guidance.

Responsibilities

• Maintain and qualify validated equipment per policies and CFR requirements.
• Lead qualification/validation activities and document outcomes.
• Supervise vendor qualification and related activities.
• Develop validation plans, protocols and reports; ensure accuracy and compliance.

Skills

cGXP knowledge

CFR Part 11

ISPE guidance

SDLC principles

Technical writing

Vendor management

Cross-functional collaboration

Documentation practices

Education

BS degree or equivalent experience

5 years FDA-regulated industry

Tools

MS Windows

Microsoft Office

Validation/Qualification tools

Job description

Bristol Myers Squibb is seeking a Manager, CSV Cell Therapy to lead the qualification and validation of equipment and computerized systems at multi-use sites. You will work with internal customers and external vendors to ensure compliance with cGXP and CFR Part 11, while driving process improvements.

You will develop validation deliverables, train staff, and manage projects within a fast-paced pharmaceutical environment, partnering with manufacturing, QA and regulatory teams.