Clean Utilities Specialist
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.
· 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.
· 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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