Senior Aseptic Process Validation Engineer — Cell Therapy

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

Benefits offered by this job

Health coverage

Wellbeing programs (EAP)

401(k) plan

Paid time off

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, Associate Aseptic Process Validation Engineer for the Devens Cell Therapy Facility in MA. This role supports aseptic validation programs and ensures manufacturing readiness, quality and regulatory compliance.

Strong communication and teamwork are essential for collaboration across sites and functions. The position requires a Bachelor’s degree in a scientific field and 2+ years in biopharma operations, with experience in aseptic processing and

Qualifications

• Bachelor’s degree in science, engineering, biochemistry or related discipline is required.
• A minimum of 2 years’ experience in biopharmaceutical operations is required.
• Experience with cGMPs and aseptic processing/validation is preferred.

Responsibilities

• Support execution of Aseptic Process Simulations/Validations (APS/APV) and Aseptic Performance Qualifications.
• Author qualification/validation documents and ensure manufacturing readiness for APS execution.
• Participate in/lead aseptic risk assessments and prepare summary reports.
• Author product impact assessments for Personnel and Environmental Monitoring related deviations.
• Lead or own site Change Controls as required.
• Support investigations and global change controls as required.
• Ensure safe, compliant cGMP operations and support regulatory inspections as SME.
• Represent MS&T on cross-functional and multi-site teams.

Skills

cGMP regulations

Aseptic processing

Regulatory audits

Verbal/written communication

Education

Bachelors in science/engineering/biochemistry or related field

Job description

Bristol Myers Squibb is seeking a Senior Specialist, Associate Aseptic Process Validation Engineer for the Devens Cell Therapy Facility in MA. This role supports aseptic validation programs and ensures manufacturing readiness, quality and regulatory compliance.

Strong communication and teamwork are essential for collaboration across sites and functions. The position requires a Bachelor’s degree in a scientific field and 2+ years in biopharma operations, with experience in aseptic processing and