Job Description
Responsibilities
- Lead and execute commissioning, qualification, and validation (CQV) activities for pharmaceutical equipment, utilities, and systems.
- Prepare and review CQV documentation, including protocols (IQ/OQ/PQ), reports, and risk assessments.
- Ensure compliance with GMP, FDA, EMA, and other global regulatory standards.
- Collaborate with cross‑functional teams including QA, Engineering, Manufacturing, and Project Management.
- Troubleshoot systems and support investigations for deviations and non‑conformances.
- Participate in FAT/SAT execution and system handover processes.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Proven experience in CQV within pharmaceutical or biotech manufacturing environments.
- Strong knowledge of GMP regulations and industry standards (ISPE, ASTM E2...