Utility Engineer
Permanent | Athlone, Ireland
Role Purpose
This role provides technical ownership for GMP-critical utility systems supporting biopharmaceutical manufacturing, including Bulk Drug Substance (BDS) and aseptic Drug Product (DP) operations. The Utility Engineer ensures utilities are operated safely, compliantly, and efficiently, while driving reliability, digital enablement, and continuous improvement across site infrastructure.
The position combines day-to-day engineering support with longer-term lifecycle management, capital project support, and performance optimisation of utility systems in a regulated environment.
Key Focus Areas
Utility System Performance
* Ensure reliable operation of GMP utilities to meet manufacturing demand, quality, and availability targets.
* Analyse system performance, trends, and alarms to improve uptime, energy efficiency, and equipment reliability.
* Support preventative and condition-based maintenance strategies.
Compliance & Validation
* Maintain utilities in a validated and inspection-ready state.
* Prepare, execute, and review URS, qualification, and periodic review documentation.
* Manage alarm limits, criticality assessments, and validated state change control in line with GMP expectations.
Digital, Data & Automation
* Use BMS, EMS, CMMS, and historian data to support operational decision-making.
* Develop dashboards and reports to track performance, energy usage, and reliability KPIs.
* Support data integrity, CSV compliance, and digital improvement initiatives.
Problem Solving & Investigations
* Lead technical troubleshooting of utility-related issues impacting manufacturing.
* Author and support deviations, investigations, and CAPAs using data-driven root cause analysis techniques.
Continuous Improvement & Lean
* Apply lean tools such as standard work, visual management, and structured problem solving to reduce waste and unplanned downtime.
* Identify and deliver energy, water, and cost reduction initiatives.
Projects & Lifecycle Support
* Support utility upgrades, expansions, and obsolescence projects from design through commissioning and handover.
* Participate in FATs, SATs, and commissioning activities.
* Coordinate vendors and contractors and review technical documentation and as-built records.
Safety, Quality & Collaboration
* Promote safe systems of work, permit-to-work compliance, and strong EHS behaviours.
* Work closely with Operations, Quality, Validation, Facilities, Digital/IT, and Finance teams to ensure aligned execution and right-first-time delivery.
On-Call Support
* Participate in out-of-hours engineering support as required to maintain continuous and compliant operations.
Technical Background
Utility Systems Experience
* GMP utilities including WFI, clean and pure steam, purified water, clean compressed air and gases, HVAC/AHU systems for classified areas, BMS/EMS, chilled and hot water systems, boilers, cooling towers, electrical distribution (LV/MV), and CIP/SIP utilities.
Validation & Engineering
* Experience supporting commissioning, qualification, and ongoing compliance of utility systems.
* Strong understanding of P&IDs, specifications, alarm management, calibration, and validated state principles.
Digital & Reliability Tools
* Experience using CMMS platforms, historians, and BMS/EMS trending tools.
* Working knowledge of data analysis, SPC, and reporting tools (e.g. Excel, Power BI or similar).
* Exposure to predictive maintenance or reliability-centred maintenance approaches is beneficial.
Experience & Qualifications
* 3–7 years' experience in pharmaceutical, biotech, or similarly regulated manufacturing environments.
* Level 8 degree (or equivalent) in Mechanical, Chemical, Electrical, Mechatronics, Pharmaceutical Engineering, or a related discipline.
* Strong understanding of GMP, HPRA/FDA utilities expectations, and EHS requirements.
* Excellent problem-solving, communication, and stakeholder engagement skills.
* Ability to work autonomously while contributing effectively within cross-functional teams.
Nice to Have
* Experience with energy management, digital twins, condition-based monitoring, or advanced utilities analytics.
* Certifications in reliability engineering, energy management, or automation/CSV.