C&Q Engineer

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.