Senior Aseptic Validation Engineer - Cell Therapy

VetJobs; Harvard (MA); On-site; USD 87,660 - 106,224; Full time

Job summary

Bristol Myers Squibb in Devens, MA is seeking a Senior Specialist, Associate Aseptic Process Validation Engineer within Cell Therapy to support APS/APV and validation documentation. This on-site role requires collaboration with cross-functional teams to ensure GMP readiness.

The candidate will lead aseptic risk assessments, author summary reports, and support regulatory inspections. A BS degree with 2+ years in biopharma is required, along with strong communication skills.

Qualifications

• Bachelor’s degree in science, engineering, biochemistry or related discipline.
• Minimum of 2 years’ experience in biopharmaceutical operations.
• Experience in cGMPs and multi-national biopharmaceutical/cell therapy regulations.
• Experience in aseptic processing/validation.
• Experience with internal and health authority audits.

Responsibilities

• Support the execution of Aseptic Process Simulations/Validations (APS/APV) and Aseptic Performance Qualifications.
• Author qualification/validation documents (procedures, protocols, reports) and ensure Manufacturing readiness for APS execution.
• Lead aseptic risk assessments and author associated summary reports.
• Author product impact assessments for Personnel and Environmental Monitoring-related deviations.
• Lead/Own site Change Controls and support investigations and global change controls.

Skills

cGMP knowledge

Aseptic processing

Audits

Communication

Education

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

Job description

Bristol Myers Squibb in Devens, MA is seeking a Senior Specialist, Associate Aseptic Process Validation Engineer within Cell Therapy to support APS/APV and validation documentation. This on-site role requires collaboration with cross-functional teams to ensure GMP readiness.

The candidate will lead aseptic risk assessments, author summary reports, and support regulatory inspections. A BS degree with 2+ years in biopharma is required, along with strong communication skills.