Senior Validation Engineer II: Equipment & Utilities

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 the qualification and validation of manufacturing and laboratory equipment at the Devens site in MA. This role focuses on maintaining validated state across facilities, utilities, and systems with adherence to established policies and procedures.

The candidate will develop qualification protocols, author validation reports, and coordinate with internal customers and external service providers to ensure timely,

Qualifications

• Bachelor of Science degree in Chemical Engineering, Mechanical Engineering, related discipline, or its equivalent is required.
• Minimum 3+ years of relevant experience with process equipment, control systems and laboratory instrumentation in an FDA regulated facility.
• Minimum of 2+ years’ experience in equipment, facility, or utility qualification.

Responsibilities

• Develops and executes validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports.
• Ensure periodic reviews and requalification is performed according to schedule.
• Author and review Development/Review of SOPs, WPs, test protocols, validation deliverables, plans and policies.
• Execute validation lifecycle maintenance and change control related activities.
• Lead qualification projects and support regulatory inspections as SME.

Skills

cGMP knowledge

Equipment qualification

Qualification lifecycle

Project management

Technical writing

Education

Bachelor of Science in Chemical/Mechanical Engineering or related

Tools

FDA/ICH compliance knowledge

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 the Devens site in MA. This role focuses on maintaining validated state across facilities, utilities, and systems with adherence to established policies and procedures.

The candidate will develop qualification protocols, author validation reports, and coordinate with internal customers and external service providers to ensure timely,