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...