CQV Engineer

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.