Clean Utilities Engineer

Our client who is a leading pharmaceutical company has a requirement for a Utility Engineer based in Waterford. This is a 23-month contract position.

This is a Senior Clean Utilities Specialist/SME and the sites technical authority for all critical utility systems supporting GMP manufacturing - including Purified Water (PW), Water for Injection (WFI), Clean Steam (CS), CIP/SIP systems, and cleanroom HVAC. This is a hands on technical expert role with 75% technical execution and 25% strategic leadership.

THE ROLE

Oversee design integrity and troubleshoot complex issues across Purified Water (PW), Water for Injection (WFI), Clean Steam (CS), CIP/SIP systems, and cleanroom HVAC.

Lead technical design reviews, author URS documents, and manage vendors/OEMs for capital projects and system upgrades.

Act as the primary SME during regulatory inspections (FDA, HPRA) and drive compliance with Pharmacopeial, ISPE, and ASTM standards.

Spearhead root cause investigations (CAPAs), drive Lean/Six Sigma initiatives, and pilot digital technologies (PAT, IoT monitoring, predictive maintenance).

Coach and upskill technical teams, while representing the site in global networks and professional communities (ISPE, ASHRAE, etc.).

Requirements

• Bachelor's degree in Engineering (Mechanical, Chemical, or related).
• 8-10+ years in GMP critical utility systems (Pharma, Biotech, or high purity manufacturing) with 5+ years in a Senior SME role.
• Deep knowledge of qualification protocols (IQ/OQ/PQ), root cause analysis, change control, and CMMS.
• Proven ability to lead audits, implement new industry standards, and mentor technical engineering teams.