Commissioning and Qualification Engineer

We are seeking a skilled C&Q Specialist to lead commissioning and qualification activities for QC laboratory systems, equipment, and support utilities. This role ensures compliance with GMP standards and regulatory requirements while supporting cross-functional teams and external vendors.

Key Responsibilities:

• Act as SME for QC laboratory C&Q scope.
• Plan, coordinate, and execute commissioning and qualification for lab systems (e.g., analytical instruments, HVAC, water systems).
• Develop and review protocols (IQ/OQ/PQ), validation plans, and reports.
• Coordinate with CSV and global IT teams.
• Identify and resolve risks, troubleshoot issues, and implement corrective actions.
• Maintain and report C&Q status to stakeholders.

Candidate Profile:

• Bachelor’s degree in Life Sciences or Engineering.
• 5+ years of CQV experience in a GMP environment.
• Proficiency with laboratory instruments (e.g., HPLC, GC, UV-Vis) and CSV for lab systems.
• Strong knowledge of IQ/OQ/PQ processes and regulatory standards (FDA, EMA, ISO).
• Experience with Kneat for CQV execution is an advantage.
• Excellent communication skills and cGMP knowledge.

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