Senior Specialist, Associate Aseptic Process Validation Engineer
Bristol Myers Squibb EU Policy · Devens, MA · 2 days ago
On-siteManufacturing$88k–$106k/yrFull-time
About the role
The Senior Specialist, Associate Aseptic Process Validation Engineer, Cell Therapy provides process aseptic validation support to the Devens Cell Therapy Facility (CTF).
Responsibilities
- Supports the execution of Aseptic Process Simulations/Validations (APS/APV) and Aseptic Performance Qualifications.
- Authors qualification/validation documents (e.g. procedures, protocols and summary reports) and ensures Manufacturing readiness for APS execution.
- Participates in/Leads aseptic risk assessments and authors associated summary reports.
- Authors product impact assessments for Personnel and Environmental Monitoring-related deviations.
- Leads/Owns site Change Controls as required.
- Supports investigations and global change controls as required.
- Ensures safe and compliant cGMP operations, maintains permanent inspection readiness, and actively supports regulatory inspections as a Subject Matter Expert.
- Serves as a MS&T representative on cross-functional and multi-site teams.
Qualifications
Knowledge of science generally attained through studies resulting in a Bachelor’s degree in science, engineering, biochemistry or related discipline, or its equivalent is required.
A minimum of 2 years’ experience in biopharmaceutical operations, or its equivalent is required.