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.