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Clean Utilities Specialist

Engineering
Dublin
Peter Paul Galligan
Temporary
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Job Reference: JO-2006-65253_1592905049

Summary:

Clean Utilities Specialist



Job Purpose:


The successful candidate will work as part of a multi-functional utilities team and will be responsible for the qualification, validation maintenance, revalidation and periodic review activities associated with GMP Critical Utility equipment and systems.



Job Responsibilities:



· Generation of qualification risk assessment/testing matrix for qualification protocols and supporting documents in line with User Requirements/Equipment Specifications and cGMP compliance standards.


· Preparation and approval of Utilities Validation SOPs


· Preparation and approval of Validation test equipment SOP's


· Management of Validation Test equipment with support from site maintenance management team. (Calibration/System Maintenance and Calibration Event handling)


· Qualification of Validation test equipment.


· Develop, review and execute GMP critical utility Performance Qualification (PQ) protocols and PQ reports for GMP Critical systems e.g. HVAC, RO/PW/WFI, Clean Steam, Clean Compressed Gasses, walk in cold storage.


· Equipment/System assessments for 'Computer System Qualification' requirements and 'Execution of Electronic Records and Electronic Signatures' requirements.


· Identify, document and track validation events


· Full oversite of all personnel and contractors participating or executing PQ activities, ensuring all team members are trained and follow the relevant site procedures.


· Responsible for ensuring documentation being leveraged for PQ testing from project commissioning phase/IQ/OQ are referenced as per associated qualification, referencing procedures.


· Responsible for validation tasks/actions associated with quality system change controls and investigations where required.


· Development/Generation of Utilities Validation Master Plan.


· Periodic review and revalidation assessment.



Education/Experience



· Minimum qualification BSc or MSc/M.Eng Degree in Engineering or equivalent discipline.


· Must have excellent verbal and written communication skills. Having a minimum of 5 years


in an Engineering CQV role with extensive cGMP experience in Commissioning Qualification & Validation, ideally covering GMP Critical Utilities Equipment Engineering.


· Have a good understanding of Instrumentation/Calibration, Utilities Equipment incl. HVAC, WFI/RO/PW, Clean Steam Gases, Refrigeration Systems.


· In depth knowledge and experience with validation test equipment/systems. A good understanding of associated Maintenance/Calibration requirements of such systems is also a requirement.


· Have the capability and experience to manage Vendors and Contractors supporting PQ activities.


· Ability to work independently and as part of a team in a cross functional collaborative environment



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Peter Paul Galligan
Peter Paul Galligan
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