Utilities Engineer

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

Job summary

CareerWise Recruitment is assisting a leading pharmaceutical company in Waterford to recruit an experienced Utility Engineer on a 23-month contract. The Senior SME will oversee PW, WFI, CS, CIP/SIP, and cleanroom HVAC, combining hands-on execution with strategic leadership.

The role requires a Bachelor's in Engineering and 8-10+ years in GMP utility systems, with 5+ years in a Senior SME capacity. You will lead audits, qualification protocols, CAPAs, and mentor teams while engaging with

Qualifications

• Bachelor's degree in Mechanical, Chemical, or related engineering field.
• 8–10+ years in GMP critical utility systems with 5+ years as SME.
• Expert in IQ/OQ/PQ qualification, change control, and CAPA processes.

Responsibilities

• Oversee design integrity and troubleshoot PW, WFI, CS, CIP/SIP, and cleanroom HVAC.
• Lead technical design reviews, author URS, manage vendors for capital projects.
• Act as primary SME during FDA and HPRA inspections and ensure compliance with standards.
• Drive root cause investigations, Lean/Six Sigma initiatives, and pilot digital technologies.
• Coach and upskill technical teams and participate in global networks.

Skills

GMP utilities

Root cause analysis

QA/QC compliance

Lean Six Sigma

CAPA investigations

Education

Bachelor's degree in Engineering

Tools

CMMS

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. The Senior Clean Utilities Specialist/SME is the site's 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.