Senior Specialist, Associate Aseptic Process Validation Engineer
Core
Supports the execution of Aseptic Process Simulations/Validations (APS/APV) and Aseptic Performance Qualifications for the Devens Cell Therapy Facility.
Role type
Senior Specialist, Associate Aseptic Process Validation Engineer
Builds
Aseptic process validation programs and manufacturing readiness for cell therapy products
Domain
Biopharmaceuticals / Cell Therapy / cGMP
Required skills
cGMP knowledge, aseptic processing/validation, clean room design, internal and health authority audits, risk assessment, change control management, deviation investigation, regulatory inspection readiness
Preferred skills
Multi-national biopharmaceutical regulations experience, cross-functional collaboration
Technologies
None explicitly stated
Responsibilities
Execute Aseptic Process Simulations/Validations (APS/APV) and Aseptic Performance Qualifications; Author qualification/validation documents; Participate in/Lead aseptic risk assessments; Author product impact assessments for deviations; Lead site Change Controls; Support investigations and global change controls; Ensure safe and compliant cGMP operations and inspection readiness; Serve as MS&T representative on cross-functional teams
Seniority
Senior Specialist, hands-on IC