CQV Engineer

Optimus Life Sciences; Wien; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Optimus Life Sciences in Vienna is seeking an experienced Senior CQV Engineer specializing in Clean Utilities to join a major long-term manufacturing and expansion programme.

You will lead CQV activities across GMP utility systems, support design review, commissioning and qualification of clean steam, HVAC interfaces, and develop DQ/IQ/OQ/PQ documentation while collaborating with QA, Validation and external vendors.

Qualifikationen

• Strong background in pharmaceutical/biotech sterile manufacturing.
• Proven CQV/validation track record for GMP clean utility systems.
• Experience with WFI, PW, Clean Steam and process gas infra.
• Experience on capital projects, expansions, upgrades or new facility builds.
• GMP knowledge including FDA, EMA and ISPE standards.

Aufgaben

• Lead CQV activities across GMP utility systems.
• Review URS documents, engineering drawings, P&IDs and risk assessments.
• Develop and execute DQ, IQ, OQ and PQ documentation.
• Review URS and regulatory documentation and support CAPA investigations.
• Collaborate with Engineering, QA, Validation, Manufacturing and external vendors.
• Drive continuous improvement and optimisation of clean utility systems.

Kenntnisse

CQV/Validation

GMP knowledge

Clean Steam

Process Gas

Capital Projects

Autonomous Work

Jobbeschreibung

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:
• Clean Steam Systems
• 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.