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 environment
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 environment
Strong understanding of GMP requirements and qualification lifecycle activities
Experience supporting qualification activities for manufacturing equipment, utilities, facilities, or laboratory system
Experience with autoclave qualification would be advantageous
Strong communication skills with experience working cross-functionally across project teams and site functions
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