Website CBS Butler
CBS Butler
Company : CBS Butler
Senior Validation Engineer
Our client are looking for an experienced Senior Validation Engineer to lead validation activities in a state-of-the-art sterile injectable and biopharmaceutical facility. This role is all about ensuring equipment, utilities, cleanrooms, and computerized systems stay fully compliant and validated, while supporting safe, high-quality manufacturing.
What You’ll Do
- Lead all aseptic filling lines, isolators/RABS, cleanrooms, critical utilities, and computerized systems.
- Plan and maintain Validation Master Plans (VMPs) and related documentation.
- Perform process and cleaning validations, including media fills.
- Validate critical utilities like WFI, clean steam, HVAC, and compressed gases.
- Drive investigations, deviations, CAPAs, change controls, and risk assessments.
What We’re Looking For
- Bachelor’s degree in Engineering or Life Sciences.
- 7+ years of hands-on validation experience in sterile injectable or biopharmaceutical manufacturing.
- Strong knowledge of FDA cGMPs, EU GMP Annex 1, and global regulatory requirements.
- Excellent technical writing and documentation skills.
Why This Role?
Take a lead role in a cutting-edge facility, driving compliance, process reliability, and continuous improvement in advanced sterile manufacturing.