Position: Project Engineer - Clean Utilities & HVAC
Location: Dublin, Ireland (Hybrid)
Contract Duration: 12-month contract
A rare opportunity for a hands-on clean utilities engineer to step into full system ownership in a regulated GMP environment
Key Responsibilities:
System Ownership & Compliance
Act as system owner for clean utilities and HVAC systems, including:
Water systems (e.g. PW/WFI)
Clean gases
Bulk chemicals
HVAC systems
Biosafety cabinets, extract systems, room classifications, and grading
Ensure ongoing regulatory compliance with internal standards and global regulations (e.g. FDA, ISO, GMP).
Represent systems during internal and external audits, confidently presenting system design, qualification, and compliance status.
Engineering & Projects
Own the design, commissioning, and qualification of new and modified clean utility and HVAC systems.
Support new facility build projects, taking ownership of systems as they are handed over to operations.
Review and approve all relevant CQV documentation (URS, FS, DS, IQ/OQ/PQ), ensuring correct execution and compliance.
Ensure specifications remain current with regulatory and industry standards
Operations & Quality Support
Provide technical support for operations, maintenance, and escalations related to clean utilities and HVAC.
Lead or support deviation investigations, including issues such as particulates, chemical excursions, or system performance failures.
Work closely with Quality, QC, and Maintenance teams to resolve issues and implement corrective actions.
Ensure maintenance activities adhere to validated and compliant states.
Required Experience & Skills
- Strong hands-on experience with clean utilities equipment and HVAC systems in a regulated GMP environment.
- Background in CQV / Qualification with the ability to review, approve, and assess compliance - not just execute protocols.
- Proven experience acting as a system owner, not solely a project manager.
- Solid understanding of GMP, FDA, ISO, and global regulatory expectations.
- Experience supporting audits, deviations, and quality systems.
- Ability to interpret technical documentation and translate regulatory requirements into practical engineering solutions.
Nice to Have
- Experience with new facility builds or major capital projects.
- Pharmaceutical, biotech, or life sciences background.
If you're comfortable standing in front of auditors explaining exactly how your systems work -and why they're compliant - we should talk.
- Strong hands-on experience with clean utilities equipment and HVAC systems in a regulated GMP environment.
