Job Description
Job Responsibilities:
- Own CSV activities for equipment, automation, and computer systems
- Perform risk assessments, review change requests, and validate test scripts
- Draft and execute validation protocols and manage GMP documentation updates
- Lead Change Control, Deviations, and CAPAs within the QMS
- Support and validate DCS (DeltaV) and MES (Syncade) systems
- Collaborate with cross-functional teams to improve validation efficiency and compliance
Skills:
- Computer System Validation (CSV) in GMP environments
- Process Control Systems & Automation
- DeltaV DCS (preferred) and MES (Syncade)
- Biotech/Pharma or biologics manufacturing experience
- QMS processes (Change Control, Deviations, CAPA)
Education/Experience:
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