Senior Validation Engineer II — Equipment & Compliance

Bristol Myers Squibb EU Policy; Harvard (MA); On-site; USD 93,000 - 112,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, Validation Engineer II to support the qualification and validation of manufacturing and laboratory equipment at multi-use sites. You will qualify new equipment, maintain validated systems and work under minimal supervision on moderate complexity projects.

Responsibilities include creating validation protocols, reports, and participating in change control processes, audits, and ensuring compliance with FDA/EMA guidelines.

Qualifications

• Knowledge of cGMP in pharmaceutical manufacturing.
• Experience with equipment, facilities, sterilization qualification and validation.
• Understanding of regulatory validation requirements (FDA/EMA/ICH Q7-Q9).
• Experience in quality systems and validation lifecycle management.

Responsibilities

• Develop and execute validation/qualification deliverables (Validation Plans, Specifications, Traceability Matrices, Summary Reports).
• Ensure periodic reviews and requalification are performed per schedule.
• Support equipment qualification and validation activities.
• Prepare and review SOPs, WPs, test protocols and validation deliverables.

Skills

cGMP knowledge

Regulatory compliance

Project management

Technical writing

Team collaboration

Problem solving

Education

Bachelor of Science in Chemical/Mechanical Engineering or related

Tools

GAMP validation concepts

Job description

Bristol Myers Squibb is seeking a Senior Specialist, Validation Engineer II to support the qualification and validation of manufacturing and laboratory equipment at multi-use sites. You will qualify new equipment, maintain validated systems and work under minimal supervision on moderate complexity projects.

Responsibilities include creating validation protocols, reports, and participating in change control processes, audits, and ensuring compliance with FDA/EMA guidelines.