C&Q Engineer

IrishJobs

Waterford, Waterford, Ireland

Waterford, Waterford, Ireland

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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.

TLNT1_IJ

Waterford, Waterford, Ireland

Sprachkenntnisse

English

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