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.
