Senior Specialist, Associate Aseptic Process Validation Engineer

Bristol Myers Squibb • Devens, MA

6d • $87,660 - $106,224 • Onsite

About The Position

The Senior Specialist, Associate Aseptic Process Validation Engineer, Cell Therapy provides process aseptic validation support to the Devens Cell Therapy Facility (CTF) and supports the facility’s aseptic process validation program. The role supports execution of aseptic process simulations and validations (APS/APV), aseptic performance qualifications, and related documentation and risk-assessment activities. It also contributes to compliant, inspection-ready cGMP operations and cross-functional and multi-site programs.

Requirements

• Bachelor’s degree in science, engineering, biochemistry, or a related discipline, or equivalent.
• A minimum of 2 years’ experience in biopharmaceutical operations, or equivalent.
• Experience with cGMPs and multinational biopharmaceutical/cell therapy regulations.
• Experience in aseptic processing/validation and facility/clean room design.
• Experience with internal and health authority audits.
• Excellent verbal and written communication skills.

Responsibilities

• Support execution of Aseptic Process Simulations/Validations (APS/APV) and Aseptic Performance Qualifications.
• Author qualification and validation documents, including procedures, protocols, and summary reports, and ensure Manufacturing readiness for APS execution.
• Participate in or lead aseptic risk assessments and author associated 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 and compliant cGMP operations, maintain permanent inspection readiness, and actively support regulatory inspections as a Subject Matter Expert.
• Serve as an MS&T representative on cross-functional and multi-site teams.
• Build and maintain collaborative relationships across the site and network, influencing site and network product/process life cycle programs.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to eligibility and applicable plan terms.
• Eligible U.S.-based exempt employees receive Flexible Time Off, subject to manager approval, and 11 paid company holidays.
• Non-exempt employees, RayzeBio employees, and employees in Puerto Rico receive 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees receive an annual Global Shutdown between Christmas Day and New Year’s Day.
• Potential eligibility for additional discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level