CQV Engineer in Wien

Senior CQV Engineer – Clean Utilities

Vienna, Austria | Hybrid / Onsite 12-Month Contract Excellent Day Rates on Offer We are currently supporting a leading pharmaceutical manufacturing organisation in Vienna in the search for an experienced Senior CQV Engineer specialising in Clean Utilities to join a major long-term manufacturing and expansion programme. This is a high-impact contract opportunity working within a complex GMP-regulated biologics and sterile manufacturing environment, supporting critical utility infrastructure across large-scale pharmaceutical operations. The successful consultant will play a key role across commissioning, qualification, validation and lifecycle management activities for critical clean utility systems, ensuring full compliance with GMP and global regulatory standards. Key Responsibilities

Lead CQV activities across critical GMP utility systems Support design review, commissioning and qualification of: Purified Water (PW) / Water for Injection (WFI) Clean Steam Systems Process Gases (Nitrogen, Oxygen, Compressed Air, CO₂) HVAC utility interfaces where applicable Develop and execute DQ, IQ, OQ and PQ documentation Review URS documents, engineering drawings, P&IDs and risk assessments Support deviation investigations, CAPAs and root cause analysis Collaborate closely with Engineering, QA, Validation, Manufacturing and external vendors Drive continuous improvement and optimisation of clean utility systems Support audits and regulatory inspections as the SME for utility systems Required Experience

Strong background within pharmaceutical, biotech or sterile manufacturing environments Proven experience delivering CQV / Validation activities for GMP clean utility systems Deep understanding of WFI, PW, Clean Steam and process gas infrastructure Experience working on capital projects, expansions, upgrades or new facility builds Strong GMP knowledge including FDA, EMA and ISPE standards Ability to work autonomously within fast-paced manufacturing environments Highly Desirable

Biologics, vaccine or cell & gene therapy experience Aseptic or sterile manufacturing exposure Cleanroom infrastructure knowledge Greenfield or brownfield commissioning experience Experience supporting regulatory inspections This is an excellent opportunity to join a highly advanced pharmaceutical environment on a long-term contract with strong extension potential and highly competitive rates.

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