Senior Aseptic Validation Engineer, Cell Therapy Impact

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

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, Associate Aseptic Process Validation Engineer, Cell Therapy for the Devens, MA facility. You will support aseptic validation programs, author key qualification documents, and lead risk assessments within a global framework.

The role focuses on aseptic processing and validation in a cell-therapy context, collaborating with multiple teams to ensure cGMP compliance and regulatory readiness. Monday–Friday, on-site at Devens.

Qualifications

• Bachelor's degree in science, engineering, biochemistry or related discipline, or equivalent.
• Minimum of 2 years’ experience in biopharmaceutical operations.
• Experience in aseptic processing/validation and clean room design.

Responsibilities

• Support 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.
• Participate in/Lead aseptic risk assessments and author summary reports.
• Author product impact assessments for Personnel and Environmental Monitoring deviations.
• Lead/Own site Change Controls as required.
• Support investigations and global change controls as needed.
• Ensure compliant cGMP operations and inspection readiness; support regulatory inspections as Subject Matter Expert.
• Serve as MS&T representative on cross-functional teams; build collaborative relationships within site/network.

Skills

cGMP experience

Aseptic processing

Validation/Qualification

Regulatory inspections

Cross-functional teamwork

Good communication

Education

Bachelor's degree in science/engineering/related discipline

Job description

Bristol Myers Squibb is seeking a Senior Specialist, Associate Aseptic Process Validation Engineer, Cell Therapy for the Devens, MA facility. You will support aseptic validation programs, author key qualification documents, and lead risk assessments within a global framework.

The role focuses on aseptic processing and validation in a cell-therapy context, collaborating with multiple teams to ensure cGMP compliance and regulatory readiness. Monday–Friday, on-site at Devens.