Job Description
Our client, a medical device company in Cork are currently looking to recruit a Senior Commissioning Engineer for their site in Cork.
Job Purpose
The role of the C&Q Engineer is to prepare and execute commissioning and qualification (where applicable) protocols for site systems / equipment such as Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, autoclaves and isolators and clean / gray utility systems (such as purified water, water for injection clean steam, HVAC, Process Gases, Steam etc.).
Job Responsibilities
- Provide input into all aspects of C&Q i.e. from design through to commissioning and qualification completion.
- Support and participate in the design of systems and equipment to ensure they comply with cGMP requirements.
- Prepare C&Q protocols as required (e.g. URS?s / SRS?s, Plans, Impact Assessments, DQ, IQ, OQ, PQ protocols and reports).
- Review and approve documents prepared by contractor organisations (e.g. vendor SAT?s, FAT?s, commissioning protocols, project change controls).
- Execute C&Q protocols as required.
- Compile relevant documentation from vendors, contractors, and other departments for inclusion in protocols / reports.
- Complete activities / deliverables in accordance with each project site change control required deliverables (from a C&Q perspective).
- Track and support the resolution of Commissioning punch list items and Qualification deviations during the C&Q execution phase.
- Prioritize C&Q activities in line with site and project schedules.
- Co-ordinate C&Q activities with project engineering, construction and site operations activities.
- Co-ordinate C&Q activities with contractors and vendors as required.
- Co-ordinate C&Q document reviews and approvals.
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C&Q System / Equipment / Components as per site procedures.
Experience - Minimum 5+ years? experience in the Pharmaceutical (API) Industry.
- Experience of commissioning and qualifying some of the following systems: Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, autoclaves and isolators and clean / gray utility systems (such as purified water, water for injection clean steam, HVAC, Process Gases, Steam etc.).
- Experience preparing and executing commissioning and qualification protocols and reports.
- Knowledge and experience of Project Delivery Processes (PDP).
- Knowledge and experience of current Good Engineering Practices (GEP).
Following would be an advantage
? Experience with use of ABB Industrial IT control systems.
? Experience of Pharmaceutical facility local and controlling instrumentation
For further information on this Senior Commissioning Engineer in Cork please contact Deirdre Finnerty on 091730022 / deirdre@ccprecruit.ie
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