Aseptic Process Validation Lead — Cell Therapy

Bristol-Myers Squibb; Massachusetts; 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 to support the Cell Therapy facility. You will contribute to aseptic process validation programs and help ensure manufacturing readiness.

The role emphasizes collaboration with MS&T and cross-functional teams, cGMP compliance, and readiness for regulatory inspections, with opportunities to impact patient outcomes through biotech innovations.

Qualifications

• Bachelor's degree in science, engineering or related field.
• Minimum 2 years of biopharma operations experience.
• Experience with aseptic processing/validation and clean room design.
• Experience with internal and health authority audits.
• Excellent verbal and written communication skills.

Responsibilities

• Support APS/APV execution and aseptic process validation.
• Author qualification/validation documents and reports.
• Lead aseptic risk assessments and change controls.
• Support investigations and regulatory inspections as SME.
• Build cross-functional relationships across site and network.

Skills

Aseptic processing

Process validation

APS/APV

Risk assessments

cGMP

Regulatory audits

Environmental monitoring

Cross-functional collaboration

Education

Bachelor's degree in science/engineering/biochemistry

Job description

Bristol Myers Squibb in Devens, MA, is seeking a Senior Specialist, Associate Aseptic Process Validation Engineer to support the Cell Therapy facility. You will contribute to aseptic process validation programs and help ensure manufacturing readiness.

The role emphasizes collaboration with MS&T and cross-functional teams, cGMP compliance, and readiness for regulatory inspections, with opportunities to impact patient outcomes through biotech innovations.