Commissioning & Qualification (C&Q) Engineer
Key Responsibilities
• Support commissioning and qualification activities across the full C&Q lifecycle (DQ, IV, OV, PQ).
• Generate, review, and execute qualification protocols and reports in compliance with GMP and ALCOA+ principles.
• Support FAT and SAT planning, documentation review, execution, and witnessing activities.
• Review supplier documentation, RTMs, and turnover packages to ensure readiness for qualification.
• Conduct installation inspections and support commissioning activities, identifying and managing punch-list items through to closure.
• Perform risk assessments and develop task-specific method statements to support safe execution of activities.
• Provide technical troubleshooting and problem-solving support during testing and qualification phases.
• Monitor progress against project schedules and escalate risks or delays where required.
• Collaborate with engineering, quality, construction, and vendor teams to ensure compliant system delivery.
Requirements
• Experience within pharmaceutical or biotechnology commissioning and qualification environments.
• Strong understanding of the C&Q lifecycle, including URS, DQ, IV, OV, and PQ.
• Familiarity with GMP requirements, ALCOA+ principles, and controlled documentation systems.
• Experience supporting FAT, SAT, commissioning, and qualification activities.
• Strong technical writing, reporting, and communication skills.
• Ability to work independently while managing multiple priorities in a site-based environment.
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