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CQ Engineer

  1. Germany, Frankfurt
Frankfurt am Main
  1. Contract
Competitive
  1. Life Sciences
38330
CQ Engineer - Germany, Frankfurt - 18 Month Contract 

This is a fantastic opportunity for a CQ Engineer to join our major, global pharmaceutical client on their latest new-build project based in Frankfurt, this is a large-scale greenfield capital project and investing more than $1bn.

What you'll do:
  • Develop and execute URS, DQ, IQ, OQ, PQ protocols for lab equipment and systems
  • Perform risk assessments to determine qualification scope and criticality
  • Lead commissioning activities, including FAT/SAT coordination with vendors
  • Ensure GMP compliance and alignment with ISPE Baseline Guides, Annex 15, and FDA 21 CFR Part 211
  • Collaborate with QA, Lab Managers, and IT to validate software-controlled instruments (e.g., LIMS, CDS)
What you'll need:
  • Bachelor’s degree in Engineering, Life Sciences, or related field
  • Requires extensive experience in CQV within pharma or biotech
  • Strong understanding of GxP, CSV, and GAMP 5 principles
  • Experience qualifying lab instruments such as HPLC, GC, UV-Vis, TOC, centrifuges, incubators
  • Proficiency in writing and executing qualification protocols
  • Familiarity with electronic documentation systems and validation lifecycle
  • Excellent communication and cross-functional collaboration skills
If this role is of interest, please apply now!
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