CQ Documentation Engineer

vor 1 Woche

Frankfurt am Main, Hessen, Deutschland QCS Staffing Vollzeit

CQ Documentation Engineer - Germany, Frankfurt - 18 Month Contract
Looking to take your career to the next level? We're recruiting for a high-impact pharmaceutical project located near Frankfurt. With major capital investment experience driving various facility build projects. This is a unique opportunity for a CQ Documentation Engineer to join a global leader in the life sciences market and play a key role in shaping the future of advanced manufacturing.

Responsibilities Include

  • Coordinate with Document Preparation Lead on deliverables and approvals using the Document Generation Tracker to manage milestones and timelines.
  • Oversee Verification Design deliverables (EDR/DQ) and review/approve vendor documentation.
  • Manage documentation for Factory Acceptance Testing (FAT).
  • Support protocol development (FAT/IV/SAT/FV) with the Document Preparation Lead.
  • Liaise with vendors to ensure GEP/GDP compliance for test documentation.
  • Contribute to CQV schedule planning and milestone tracking.
  • Lead protocol review/approval in KNEAT and manage IV execution (walkdowns, tag verification, loop checks, STW, PSSR, DSTW).
  • Lead FV execution activities (start-up, debugging, ACO, SAT, phase/recipe testing).
  • Manage the timely closure of all CQV Punchlist items
  • Liaise and utilize Engineering Change Management System (ECM)
  • Review and approval of all Vendor Turnover Packages and Field Turnover Packages against the VDR and to ensure these support the Validation Requirements for the system

Key requirements include:

  • Prepare CSRs (Commissioning Summary Reports) for executed documentation
  • Ensure all the requirements for the IOQ summary reports are available and the good engineering and documentation practices have been followed throughout.
  • Review all vendor and site change controls for impact to the completed testing as required.
  • Generate Project specific SOP's / other documentation as applicable
  • Support CQV and QA programmes as required

Don't miss your chance to be part of something extraordinary, apply now and let's talk

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