C&Q Engineer.

Summary

Our client, a biopharmaceutical company in Waterford, is looking for an experienced C&Q Engineer. The successful candidate will support commissioning, qualification, and validation activities across manufacturing systems, utilities, laboratory equipment, and facilities within a GMP-regulated environment. The role will involve supporting CAPEX projects and ensuring systems are qualified and maintained in compliance with regulatory and quality requirements.

Responsibilities

• Support commissioning and qualification activities across manufacturing equipment, utilities, laboratory systems, and facilities.
• Execute qualification lifecycle activities including planning, protocol generation, execution, deviation management, and final reporting.
• Support qualification activities for clean utilities systems including Purified Water (PW), Water for Injection (WFI), Clean Steam, and Process Gases.
• Support qualification activities for laboratory equipment and laboratory systems.
• Participate in commissioning and qualification activities associated with manufacturing equipment and process systems.
• Support qualification and validation activities associated with CAPEX projects from design through to project completion.
• Develop, review, and execute qualification documentation including IQ, OQ, PQ protocols and associated reports.
• Work closely with Engineering, Manufacturing, Quality, Validation, and project teams to ensure successful project delivery.
• Support investigation activities, deviations, change controls, and CAPA actions associated with qualification activities.
• Ensure all activities are executed in compliance with GMP requirements, internal procedures, and regulatory expectations.
• Participate in FATs, SATs, walkdowns, and system turnover activities as required.
• Support continuous improvement activities within commissioning, qualification, and validation processes.

Qualifications & Experience

• Degree or equivalent qualification in Engineering, Life Sciences, or a related technical discipline.
• Experience in a C&Q, Validation, or Engineering role within pharmaceutical, biotechnology, or regulated manufacturing environments.
• Experience supporting laboratory systems qualification.
• Experience with clean utilities commissioning and qualification including PW, WFI, Clean Steam, and Process Gases.
• Experience working on CAPEX projects within GMP-regulated environments.
• Strong understanding of GMP requirements and qualification lifecycle activities.
• Experience supporting qualification activities for manufacturing equipment, utilities, facilities, or laboratory systems.
• Experience with autoclave qualification would be advantageous.
• Strong communication skills with experience working cross-functionally across project teams and site functions.