Senior Validation Engineer II — Pharma Equipment

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

Benefits offered by this job

Flexible Time Off

11 paid holidays

Comprehensive benefits

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, Validation Engineer II to support qualification of manufacturing equipment and facilities at a multi-use site in Devens, MA. You will work with internal customers and external service providers to ensure validated state across systems.

The role emphasizes developing protocols, maintaining change controls, and delivering timely validation deliverables while upholding cGMP and regulatory guidelines.

Qualifications

• Familiarity with cGMP in pharmaceutical manufacturing.
• Experience with equipment, facility, sterilization commissioning and qualification.
• Knowledge of validation lifecycle and regulatory guidelines (FDA/EMA).

Responsibilities

• Develops and executes validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports.
• Supports equipment qualification and validation activities.
• Author and review SOPs, WPs, test protocols, validation deliverables, plans and policies.
• Maintenance of validation lifecycle including change controls and revalidation programs.
• Execute portfolio of limited scope and complex validation projects under deadlines.

Skills

GAMP validation concepts

cGMP knowledge

Project management

Technical writing

Communication skills

Education

Bachelor of Science in Chemical or Mechanical Engineering

Job description

Bristol Myers Squibb is seeking a Senior Specialist, Validation Engineer II to support qualification of manufacturing equipment and facilities at a multi-use site in Devens, MA. You will work with internal customers and external service providers to ensure validated state across systems.

The role emphasizes developing protocols, maintaining change controls, and delivering timely validation deliverables while upholding cGMP and regulatory guidelines.