CQV Engineer

JobsinAustria; Wien; Hybrid; EUR 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Excellent day rates

Zusammenfassung

JobsinAustria is seeking a Senior CQV Engineer – Clean Utilities in Vienna, Austria. The role is a 12-month contract with Hybrid / Onsite work arrangements and excellent day rates on offer.

You will join a major expansion programme, delivering CQV activities within a GMP-regulated biologics and sterile manufacturing environment across PW, WFI, Clean Steam and process gases. The position requires strong autonomy and cross-functional collaboration.

Qualifikationen

• Strong background within pharmaceutical, biotech or sterile manufacturing environments.
• Proven experience delivering CQV / Validation activities for GMP clean utility systems.
• Deep understanding of PW (Purified Water), WFI (Water for Injection) and clean utilities infrastructure.

Aufgaben

• Lead CQV activities across critical GMP utility systems.
• Support design review, commissioning and qualification of PW / WFI, Clean Steam, Process Gases.
• 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.

Kenntnisse

CQV experience

Validation

GMP knowledge

Pharma/Biotech

Autonomous work

Jobbeschreibung

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.