Clean Utilities Engineer

Careerwise Recruitment; Waterford; On-site; EUR 90,000 - 130,000; Full time

Job summary

Careerwise Recruitment is recruiting a Utility Engineer for a leading pharma site in Waterford on a 23-month contract. The Senior SME will own GMP critical utility systems including Purified Water, Water for Injection, Clean Steam, CIP/SIP and cleanroom HVAC, with 75% hands-on execution and 25% strategic leadership.

The role requires 8–10+ years in GMP utilities, a Bachelor’s degree in Engineering, and experience leading audits, qualification protocols, and vendor management.

Qualifications

• Bachelor’s degree in Mechanical, Chemical, or related engineering.
• 8–10+ years in GMP critical utility systems in pharma or high-purity manufacturing.
• 5+ years in a Senior SME role with audits, qualification protocols, and change control.

Responsibilities

• Oversee design integrity and troubleshoot PW, WFI, CS, CIP/SIP systems, and cleanroom HVAC.
• Lead technical design reviews and author URS documents; manage vendors/OEMs for capital projects.
• Act as primary SME during regulatory inspections (FDA, HPRA) and ensure compliance with Pharmacopeial, ISPE, and ASTM standards.
• Drive CAPAs, Lean/Six Sigma initiatives, and pilot digital technologies (PAT, IoT, predictive maintenance).
• Coach and upskill technical teams and represent the site in global networks (ISPE, ASHRAE).

Skills

GMP utilities

IQ/OQ/PQ

Root cause analysis

Change control

CMMS

Audits

Lean Six Sigma

PAT

IoT

Mentor teams

Vendor management

Education

Bachelor's degree in Engineering

Job description

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.