CSV Cell Therapy Manager | Validation & QA Lead

Bristol-Myers Squibb Co; Bend (OR); 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 equipment qualification, validation, and complex process improvements at a multi-site level. The role emphasizes strong collaboration with manufacturing, QA, and IT teams to ensure compliant operations.

The position requires a BS degree with at least 5 years in an FDA-regulated environment, plus experience in validation strategies, technical writing, and customer-facing problem solving.

Qualifications

• Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.
• Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.
• Strong working knowledge of SDLC principles and standards.
• Ability to work with the end user to identify and document User and Functional Requirements.
• Knowledge of pharmaceutical laboratory and manufacturing systems.

Responsibilities

• Maintains all qualified and validated equipment and systems in compliance with policies, guidelines, and procedures.
• Investigates and resolves Deviations, CAPA investigations and other issues.
• Configures and documents the configuration of computerized systems to CFR 21 Part 11 requirements.
• Supports execution of qualifications and validation protocols.
• Supervises vendors for qualification functions.

Skills

cGXP compliance

21 CFR 11

SDLC

Documentation

MS Office

Education

BS degree

Tools

MS Windows

Job description

Bristol Myers Squibb is seeking a Manager, CSV Cell Therapy to lead equipment qualification, validation, and complex process improvements at a multi-site level. The role emphasizes strong collaboration with manufacturing, QA, and IT teams to ensure compliant operations.

The position requires a BS degree with at least 5 years in an FDA-regulated environment, plus experience in validation strategies, technical writing, and customer-facing problem solving.