CQ Engineer fill finish

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Job type
Contract
Location
Frankfurt am Main, Hessen, Germany
Ref. No
38678
CQ Engineer fill finish - US, North Carolina - 12 Month Contract

Our client, a global pharmaceutical manufacturing organization are looking for a talented CQ Engineer fill finish to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.

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
  • Maintain traceability matrices, deviation logs, and change control records
  • Support data integrity reviews and audit trail verification
  • Provide technical support during regulatory inspections and internal audit
What you'll need:
  • Bachelor’s degree in Engineering, Life Sciences, or related field
  • 3 years of experience in CQV within pharma or biotech
  • Proficiency in writing and executing qualification protocols
  • Familiarity with electronic documentation systems and validation lifecycle
  • Excellent communication and cross-functional collaboration skills
  • Advanced degree (MSc, MEng) in relevant discipline
  • Experience with automation systems or networked lab equipment
  • Knowledge of Annex 11, Part 11, and data integrity best practices
  • Prior experience in greenfield or tech transfer projects

If you are interested, please apply now for immediate consideration and further information.

Apply now

Please complete the form for your job application, or feel free to reach out to our consultant directly for assistance.

Contact us

Caroline O`Sullivan
Business Unit Leader
Caroline O`Sullivan

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