Sr Specialist, Associate Aseptic Process Validation Devens, MA

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At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition backed by a best-in-the-industry team and long-term commitment we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself accelerate your career and give new hope to patients theres no better place than here at BMS with our Cell Therapy team.

The Senior Specialist Associate Aseptic Process Validation Engineer Cell Therapy provides process aseptic validation support to the Devens Cell Therapy Facility (CTF). The Senior Specialist supports the aseptic process validation program for the Devens Cell Therapy Facility (CTF).

Shifts Available:

Monday Friday Standard Working Hours

Responsibilities:

Responsible for supporting 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
Builds and maintains effective collaborative relationships across the site and network influencing site and network product/process life cycle programs
Knowledge and Skills:

Experience in cGMPs and multi-national biopharmaceutical/cell therapy regulations
Experience in aseptic processing/validation and facility/clean room design.
Experience with internal and health authority audits
Excellent verbal/written communication skills