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.
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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.
#J-18808-Ljbffr
