Senior Aseptic Validation Engineer, Cell Therapy

Bristol-Myers Squibb Company; Harvard (MA); On-site; USD 88,000 - 106,000; Full time

Benefits offered by this job

Flexible Time Off

11 company holidays

Paid vacation

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, Associate Aseptic Process Validation Engineer, Cell Therapy to support the Devens Cell Therapy Facility. The role focuses on aseptic validation programs, qualifications, and risk assessments within a GMP environment.

Responsibilities include authoring validation documents, participating in site change controls, and ensuring regulatory inspection readiness as a subject matter expert.

Qualifications

• Experience in cGMPs and multinational biopharmaceutical regulations.
• Experience in aseptic processing/validation and clean room design.
• Experience with internal and health authority audits.

Responsibilities

• Support APS/APV execution and aseptic validation activities.
• Author qualification/validation documents and ensure manufacturing readiness for APS.
• Lead aseptic risk assessments and summarize reports.

Skills

cGMP compliance

Aseptic processing/validation

Regulatory audits

Communication skills

Education

Bachelor’s degree in science/engineering/biochemistry

Job description

Bristol Myers Squibb is seeking a Senior Specialist, Associate Aseptic Process Validation Engineer, Cell Therapy to support the Devens Cell Therapy Facility. The role focuses on aseptic validation programs, qualifications, and risk assessments within a GMP environment.

Responsibilities include authoring validation documents, participating in site change controls, and ensuring regulatory inspection readiness as a subject matter expert.