QA Cleaning Validation Specialist | Greenfield C&Q | Pharma GMP | Basel
You will play a key role in ensuring robust contamination control strategies and full GMP compliance for a major greenfield programme currently entering its final Commissioning & Qualification phase. This is a hands‑on Cleaning Validation specialist role within a final‑phase C & Q greenfield programme—not generalist QA, equipment qualification only, not Quality Control.
Key Information
* Duration: 6 months
* Start date: ASAP—no later than June 2026
* Experience: 3–5+ years in Cleaning Validation/QA Validation
* Industry: Pharma/Biotech (GMP environment)
Programme Context
A new building with new production lines is being built on‑site. The programme is now entering its final phase (Phase 3), with full Commissioning & Qualification activities underway. You will be a central QA contributor to cleaning validation across the new assets.
Key Responsibilities
* Collaborate with QA, Production, Engineering and QC teams across the C & Q phase
* Ensure compliance with EUGMP Annex 15, FDA guidelines and internal standards
Your Profile
* Master's degree in Pharmaceutical Sciences, Chemistry, Biotechnology or Engineering
* Strong hands‑on command of MACO/HBEL acceptance criteria
* Solid experience with CIP/SIP systems validation and/or equipment qualification
* Strong knowledge of EUGMP Annex 15 and FDA cleaning validation guidance—applied on production floor, not purely documentary
* Experience in greenfield/new‑line C & Q environments is a strong plus
Why This Role
* Greenfield programme with high technical visibility
* Central contribution during the final C & Q phase of a new manufacturing building
* Full ownership of cleaning validation strategy on new lines
* Strong cross‑functional collaboration (QA, Production, Engineering, QC)
Process
Confidential recruitment process with response within 48 hours. Immediate need—priority given to relevant applications.
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