Aseptic Process Validation Engineer – Cell Therapy

Bristol Myers Squibb; Massachusetts; On-site; USD 88,000 - 106,000; Full time

Job summary

Bristol Myers Squibb in Devens, MA is seeking an experienced specialist to support execution of aseptic process simulations/validations and aseptic qualifications. You will author qualification and validation documents, ensuring Manufacturing readiness for APS execution and participate in risk assessments.

The role requires working with cross-functional teams, leading change controls, supporting investigations, and acting as SME for regulatory inspections.

Qualifications

• Experience with cGMPs and international biopharma regulations.
• Experience in aseptic processing and cleanroom design.
• Experience with internal and regulatory audits.
• Strong verbal and written communication skills.

Responsibilities

• Support execution of APS/APV and aseptic performance qualifications.
• Authors qualification/validation documents and ensures manufacturing readiness.
• Lead aseptic risk assessments and summary reports.
• Prepare product impact assessments for monitoring deviations.
• Lead site Change Controls and support investigations.
• Assist regulatory inspections as SME, ensure compliant operations.
• Represent MS&T on cross-site teams and collaborate across network.

Skills

cGMP and biopharma regulations

Aseptic processing/validation

Audits (internal/regulatory)

Excellent communication

Education

Bachelor’s degree in science/engineering/biochemistry or related discipline

Job description

Bristol Myers Squibb in Devens, MA is seeking an experienced specialist to support execution of aseptic process simulations/validations and aseptic qualifications. You will author qualification and validation documents, ensuring Manufacturing readiness for APS execution and participate in risk assessments.

The role requires working with cross-functional teams, leading change controls, supporting investigations, and acting as SME for regulatory inspections.