Senior Validation Engineer II: Equipment & Facility Validation

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

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, Validation Engineer II in Devens, MA to lead validation and qualification activities for equipment, facilities and utilities across multi-use sites. You will develop protocols, reports and ensure lifecycle management within a regulated manufacturing environment.

The role emphasizes collaboration with internal customers, external providers, and a strong emphasis on cGMP compliance, regulatory readiness, and continuous improvement in

Qualifications

• Bachelor of Science in Chemical Engineering or Mechanical Engineering required.
• Minimum 3+ years' experience with process equipment and automation in FDA-regulated manufacturing.
• Minimum 2+ years' experience in equipment, facility, or utility qualification.
• Familiarity with cGMP and regulatory guidelines (FDA/EMA) preferred.

Responsibilities

• Develops and executes validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports.
• Ensures periodic reviews and requalification is performed according to schedule.
• Supports equipment qualification and validation activities.
• Develops qualification protocols and associated reports while adhering to a change management process.
• Authors and reviews SOPs, WPs, test protocols, validation deliverables, plans and policies as needed.
• Executes validation lifecycle maintenance including document hierarchy, change controls, shutdown/changeover and revalidation programs.

Skills

Validation planning

Project management

Technical writing

Quality systems

Education

Bachelor of Science in Chemical/Mechanical Engineering

Job description

Bristol Myers Squibb is seeking a Senior Specialist, Validation Engineer II in Devens, MA to lead validation and qualification activities for equipment, facilities and utilities across multi-use sites. You will develop protocols, reports and ensure lifecycle management within a regulated manufacturing environment.

The role emphasizes collaboration with internal customers, external providers, and a strong emphasis on cGMP compliance, regulatory readiness, and continuous improvement in