Senior Validation Engineer II – Equipment & GMP Systems

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

Benefits offered by this job

Flexible Time Off

11 paid holidays per year

Paid vacation (160 hours per year for新

Global Shutdown between Christmas and

Job summary

Bristol Myers Squibb seeks a Senior Specialist, Validation Engineer II to support equipment qualification and validation at the Devens, MA site. You will develop validation plans, review SOPs, and ensure timely completion of qualification deliverables, coordinating with internal customers and external providers.

The role requires strong knowledge of cGMP, regulatory guidelines (FDA/EMA), and project management to maintain validated state of equipment and facilities.

Qualifications

• Knowledge of engineering principles and validated manufacturing environments.
• Experience with qualification/validation lifecycle in regulated facilities.
• Familiar with FDA/EMA regulatory expectations for biologics and equipment.
• Lean and Six Sigma concepts are a plus.
• Strong communication and documentation skills.

Responsibilities

• Develops and executes validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports.
• Ensures periodic reviews and requalification is performed per schedule.
• Supports equipment qualification and validation activities.
• Develops qualification protocols and reports, adhering to change controls.
• Authors and reviews SOPs, WPs, test protocols, validation deliverables and policies.
• Executes validation lifecycle maintenance including document hierarchy and change-control tracking.
• Manages revalidation and cleaning monitoring programs as needed.
• Executes portfolio of limited scope and complex validation projects under deadlines.
• Maintains familiarity with BMS directives and industry guidelines on validation.

Skills

cGMP knowledge

Validation expertise

Regulatory guidance (FDA/EMA)

Project management

Technical writing

Team collaboration

Education

Bachelor of Science in Chemical or Mechanical Engineering or related

Job description

Bristol Myers Squibb seeks a Senior Specialist, Validation Engineer II to support equipment qualification and validation at the Devens, MA site. You will develop validation plans, review SOPs, and ensure timely completion of qualification deliverables, coordinating with internal customers and external providers.

The role requires strong knowledge of cGMP, regulatory guidelines (FDA/EMA), and project management to maintain validated state of equipment and facilities.