We are working with a large business based in Newcastle who have a new position for a Commissioning and Qualification Engineer.  The ideal person will have strong experience of GMP.

 

 

Key Responsibilities:

  • Work closely with the general contractor for the equipment and facility fit out
  • Review of technical content of equipment supplier test protocols (GEP and GMP).
  • Review of technical content of GEP commissioning tests.
  • Lead execution of C&Q test activities to agreed sequence and enable delivery of C&Q elements for the project throughout all project phases.
  • Generation and Execution of Design Qualification protocols
  • Review and Execution and/or Witnessing of Factory Acceptance Test protocols
  • Review and Execution and/or Witnessing of Site Acceptance Test / Commissioning protocols.
  • Generate Installation / Operational Qualification protocols.
  • Review and Execution and/or Witnessing of Installation Qualification protocols.
  • Review and Execution and/or Witnessing of Operational Qualification protocols.
  • Coordination of C&Q witnessing activities.
  • During the execution phase, arrange daily meetings to ensure schedule is being progressed as agreed.
  • Develop and agree as built documentation requirements to meet expectations.
  • Measure and report progress on C&Q elements, communicate corrective action when necessary.
  • Working with company SME’s, assure that computer validation will be considered appropriately (during the concept scoping phase).
  • Integrate project C&Q activities into site guidance for Start-Up.

 

 

Your Background:

  • Educated to degree level or equivalent
  • Must have GMP and GEP experience
  • Must be able to interpret and review written technical documentation from equipment suppliers
  • Must be a good communicator and be able to confidently present on C&Q status when required
  • Experience of working on C&Q for new build projects, experience of working in different countries is desirable
  • Experience of writing Commissioning, IQ and OQ protocols
  • Experience of executing FAT, SAT, Commissioning, IQ and OQ protocols
  • Must be able to competently generate Technical Reports (GEP and GMP)
  • Experience of integrating project C&Q activities into site activities
  • Must have in depth knowledge of all C&Q elements and associated criticality in line with ISPE recommended deliverables
  • Must be able to provide knowledge on boundary definition.

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