Senior Specialist, Associate Aseptic Process Validation Engineer
Core
Supports the aseptic process validation program for the Devens Cell Therapy Facility by executing Aseptic Process Simulations/Validations (APS/APV) and ensuring manufacturing readiness.
Role type
Senior Specialist, Associate Aseptic Process Validation Engineer
Builds
Aseptic process simulations, validations, and performance qualifications for cell therapy products
Domain
Biopharmaceuticals / Cell Therapy / cGMP Manufacturing
Required skills
cGMP knowledge, aseptic processing/validation, clean room design, risk assessment, change control, deviation analysis, regulatory inspection readiness
Preferred skills
Multi-national biopharmaceutical regulations, internal/health authority audits
Technologies
None stated
Responsibilities
Execute Aseptic Process Simulations/Validations (APS/APV) and Aseptic Performance Qualifications; Author qualification/validation documents (procedures, protocols, summary reports); Participate in/Lead aseptic risk assessments; Author product impact assessments for monitoring deviations; Lead site Change Controls; Support investigations and global change controls; Ensure safe and compliant cGMP operations and inspection readiness
Seniority
Senior Specialist, 2+ years experience