|Job Title:||C&Q Engineer|
|Temp or Perm:||Contract Role|
NRL are currently recruiting on behalf of a large engineering company for C&Q Engineers to work in Macclesfield on a 3-5 year contract.
About the role:
- Acting on behalf of the client as quality control within the CQ phase of project/facility delivery, to ensure that third party contractors/sub-contractors are executing CQ activities to the required standards
- Client review and approval of the Commissioning Qualification or Validation Master Plans
- Client review and approval of Risk Assessment protocols (System and Component Impact Assessment)
- Client review and approval of Design Qualification protocols as applicable (both before and after execution)
- Client review and approval of Installation Qualification protocols as applicable (both before and after execution)
- Client review and approval of Operational Qualification protocols as applicable (both before and after execution)
- Prepare and execute Performance Qualification protocols as applicable
- Client review and approval of cGMP change control system during the validation programme, as applicable
- Review design documentation to ensure CQV and general cGMP requirements are being provided for (as applicable)
- Client liaison with construction and relevant contractors for effective system handover both mechanical and electrical
- Client review and approval of cGMP change control system during the CQ lifecycle
What you will need:
- Good communication skills and ability to negotiate and influence others including building and maintaining effective relationships with multiple stakeholders
- CQV Engineer: A degree in chemical, mechanical, or electrical engineering or equivalent/A degree in Chemistry, Microbiology, Physics, Biochemistry or equivalent.
- A certificate/diploma in similar areas with appropriate industrial experience
- Experience of Commissioning Qualification and Validation in the pharmaceutical industry.
- Security cleared to SC level.
- Experience with Regulatory and industry standards for GMP and GEP
- Experience using the ISPE baseline guides
- Good team player
- Good oral and written communication skills
What’s in it for you?
- Potential for up to 5 years work
- Competitive rates