C&Q Engineer
Scientificjobs
Cork
5d ago

We’re currently recruiting for an exciting opportunity with an award winning pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

  • Update the SLIA as required.
  • Prepare Tag list for each system with Project Engineer
  • Prepare the CLIA for each system with Project Engineer
  • Preparation of Factory Acceptance Test Protocols (FAT's), Commissioning Test Plans (CTP's), Installation & Operational Qualification Protocols (IOQ's) and Performance Qualification (PQ) Protocols.
  • Reviewing the FAT, CTP, IOQ & PQ Protocols prior to execution
  • Identifying appropriate personnel to review and approve the test Protocols pre & post execution
  • Witness execution of leveraged tests in FAT's & CTP's
  • Ensuring that leveraged FAT & CTP testing is completed correctly.
  • Execute 100% review of all test records & reportable results for accuracy, completeness & compliance with pre-established acceptance criteria
  • Raise Commissioning Change Notifications (CCN's) for any changes that arise during execution of the FAT, CTP or IOQ tests
  • Organise all necessary Vendor and craft support required to execute tests in the FAT's, CTP's, IOQ’s & PQ’s.
  • Raise and follow to closure all deviations raised during the execution of FAT's, CTP's, IOQ's &PQ’s
  • Qualifications & Experience

  • University degree in a related discipline preferred.
  • Relevant experience working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
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