Senior Specialist, Associate Aseptic Process Validation Engineer
Bristol Myers Squibb
August 12, 2026
Remote friendly (Devens, MA)
United States
Operations
Shifts Available:
- Monday–Friday, Standard Working Hours
Responsibilities:
- Support execution of Aseptic Process Simulations/Validations (APS/APV) and Aseptic Performance Qualifications.
- Author qualification/validation documents (procedures, protocols, summary reports) and ensure Manufacturing readiness for APS execution.
- Participate in/lead aseptic risk assessments; author associated summary reports.
- Author product impact assessments for Personnel and Environmental Monitoring-related deviations.
- Lead/own site Change Controls as required; support investigations and global change controls as required.
- Ensure safe, compliant cGMP operations; maintain inspection readiness and support regulatory inspections as a Subject Matter Expert.
- Serve as an MS&T representative on cross-functional/multi-site teams and build collaborative relationships to influence product/process life cycle programs.
Knowledge & Skills:
- 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.
Basic Requirements:
- Bachelor’s degree in science, engineering, biochemistry, or related field (or equivalent).
- Minimum 2 years’ experience in biopharmaceutical operations (or equivalent).
Compensation/Benefits (as listed):
- Devens, MA, US: $87,660–$106,224.
- Health coverage (medical/pharmacy/dental/vision), wellbeing support, 401(k), disability and life insurance; PTO options per employment type.
- Monday–Friday, Standard Working Hours
Responsibilities:
- Support execution of Aseptic Process Simulations/Validations (APS/APV) and Aseptic Performance Qualifications.
- Author qualification/validation documents (procedures, protocols, summary reports) and ensure Manufacturing readiness for APS execution.
- Participate in/lead aseptic risk assessments; author associated summary reports.
- Author product impact assessments for Personnel and Environmental Monitoring-related deviations.
- Lead/own site Change Controls as required; support investigations and global change controls as required.
- Ensure safe, compliant cGMP operations; maintain inspection readiness and support regulatory inspections as a Subject Matter Expert.
- Serve as an MS&T representative on cross-functional/multi-site teams and build collaborative relationships to influence product/process life cycle programs.
Knowledge & Skills:
- 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.
Basic Requirements:
- Bachelor’s degree in science, engineering, biochemistry, or related field (or equivalent).
- Minimum 2 years’ experience in biopharmaceutical operations (or equivalent).
Compensation/Benefits (as listed):
- Devens, MA, US: $87,660–$106,224.
- Health coverage (medical/pharmacy/dental/vision), wellbeing support, 401(k), disability and life insurance; PTO options per employment type.