We are seeking experienced CQV professionals and Project Managers with strong backgrounds in GxP‑regulated pharmaceutical and biotechnology manufacturing environments. These roles support complex capital and remediation programs across clean utilities, process systems, and control systems within lean qualification frameworks.Roles available are:
Senior CQV Engineer (May–Sept)
- Lead CQV protocol authoring and execution (IV/OV) using Kneat
- Plan and execute CQV activities, FAT/SAT, commissioning, and start‑up
- Maintain GxP documentation, manage changes, and issue reports
- 7+ years CQV experience, strong GxP knowledge, proven utilities qualification
- Own end‑to‑end CQV delivery across utilities plants
- Lead resources, schedules, risk‑based qualification, and governance
- Ensure compliant delivery of all CQV lifecycle documents in Kneat
- 10+ years pharma/biotech PM experience, strong CQV and utilities background
- Provide CQV SME support for clean utilities and process systems
- Author/review GxP documents and support commissioning and verification
- Execute FAT/SAT and IQ/OQ within lean frameworks using Kneat
- 7+ years CQV experience, utilities, HVAC, cleanrooms (CIP/bulk systems a plus)
- Full job descriptions and responsibilities will be outlined during the shorlisting process
- WHVs with previous project engineering experience within the pharma / biotech industry are encouraged to apply!
To submit your application in strict confidence, click the 'apply' button. If you require further information, please contact Voula Triantafillou on 0437 853 201.