Commissioning & Qualification (C&Q) Engineer
This role is responsible for supporting commissioning, qualification, and validation activities across manufacturing, utility, facility, and laboratory systems within a regulated environment. The position involves ensuring systems are installed, tested, and qualified in accordance with GMP requirements and project timelines.
Responsibilities
Support commissioning and qualification activities for manufacturing equipment, utilities, facilities, and laboratory systems.
Execute qualification lifecycle documentation including protocols, test scripts, reports, and deviation management.
Perform commissioning and qualification of clean utilities including Purified Water (PW), Water for Injection (WFI), Clean Steam, and Process Gas systems.
Support laboratory equipment and system qualification activities.
Participate in CAPEX projects, ensuring qualification deliverables are completed in line with project schedules.
Assist with risk assessments, change controls, investigations, and CAPA activities related to qualification work.
Coordinate with engineering, operations, quality, and project teams to ensure successful system handover and compliance.
Support GMP inspections, audits, and regulatory requirements through accurate documentation and record management.
Requirements
Degree or equivalent qualification in Engineering, Life Sciences, or a related technical discipline.
Experience in a Commissioning & Qualification, Validation, or Engineering role within the pharmaceutical, biotechnology, or other regulated manufacturing industry.
Strong knowledge of GMP regulations and qualification lifecycle activities.
Experience qualifying manufacturing equipment, utilities, facilities, or laboratory systems.
Experience with clean utility commissioning and qualification, including PW, WFI, Clean Steam, or Process Gases.
Laboratory systems qualification experience is desirable.
Autoclave qualification experience would be advantageous.
Experience supporting CAPEX projects within GMP-regulated environments is preferred.
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