Utility Engineer

The Utility Engineeris responsible forthe reliable, compliant, and cost-effective operation of GMP-critical utilities supporting both Bulk Drug Substance (BDS) operations and aseptic Drug Product (DP) fill-finish. Reporting to the Senior Manager, Utilities, this role executes day-to-day technical ownership, continuous improvement, and lifecycle management of utilities through the application of AI-enabled and digital strategies, lean transformation, and disciplined financial stewardship. Scope includes WFI/clean steam/pure steam, purified water, clean compressed gases, HVAC/AHU with BMS/EMS, chilled/hot water, boilers, electrical distribution (LV/MV), sterile utilities, and associated monitoring and control systems.

Principle Responsibilities

• Utilities Operations & Reliability:Operateandoptimizeutility systems to meet capacity, quality, and availability targets across BDS and DP. Monitor trends, respond to alarms, and execute precision maintenance to improve uptime, MTBF, and energy performance.

• AI & Digital Execution: Build andmaintaindata pipelines and dashboards from CMMS, BMS/EMS, and historians; apply advanced analytics and support machine learning models for predictivemaintenance, anomaly detection, and energy optimization. Ensure data integrity and CSV-aligned changes.

• Lean & Continuous Improvement: Implement 5S, Standard Work, visual management, and Kaizen. Use structured problem-solving, FMEA, and RCM inputs to reduce unplanned downtime, nuisance alarms, and utility losses; document and sustain improvements.

• Compliance & Qualification: Execute andmaintainURS, DQ/IQ/OQ/PQ documentation, periodic reviews, alarm/limit management, and criticality assessments. Ensure utilitiesremainin validated state and compliant with GMP, HPRA/FDA, EHS, and environmental requirements.

• Quality & EHS:Maintainutility quality specifications (e.g., WFI micro/TOC/conductivity, clean steam quality, classified area environmental controls). Complete risk assessments (HAZOP), support audits/inspections, and drive safe systems of work and permit-to-work adherence.

• Troubleshooting & Investigations: Lead/author technical investigations, deviations, and change controls; perform data-driven RCA and implement effective CAPAs with verification of effectiveness.

• Project Support & Start-up: Support utilities projects, upgrades, and obsolescence programs from scope/URS through FAT/SAT, commissioning, and handover. Coordinate contractor/vendor activities and ensure as-built documentation accuracy.

• Financial Stewardship: Track and report utilities OPEX drivers (energy, water, maintenance, spares).Identifyand deliver cost and energy savings; contribute to business cases/CER inputs and lifecycle cost analyses.

• Stakeholder Collaboration: Partner with Operations, Quality, Validation, EHS, Facilities, Digital/IT, and Finance for scheduling, shutdown coordination, change control, and right-first-time execution; provide clear technical communication and updates.

• Documentation & CMMS:MaintainSOPs, work instructions, P&IDs, datasheets, loop sheets, and calibration records. Plan and close work orders and PMs in the CMMS with high data quality and cGMP documentation standards.

• On-Call/Shift Support: Provide out-of-hours engineering support as required tomaintaincompliant and continuous operations.

Qualifications

• Experience: 3–7 years in Pharmaceutical/Biotech or highly regulated manufacturing with hands-on ownership of utility systems supporting BDS and/or DP aseptic operations.

• Technical Expertise: Working knowledge of WFI generation/storage/distribution, clean/pure steam, purified water, cleancompressed air/gases (e.g., nitrogen), HVAC/AHU for classified areas, BMS/EMS, chilled/hot water systems, boilers, cooling towers, electrical distribution (LV/MV), and CIP/SIP utilities.

• Commissioning & Validation:Proficiencywith URS, DQ/IQ/OQ/PQ, calibration/metrology, alarm philosophy, andmaintainingvalidated state; competent with P&IDs, URS/specs, and FAT/SAT protocols.

• AI/Digital Skills: Practical experience using data historians, BMS/EMS trends, CMMS analytics, and dashboards; familiarity with SPC, basic scripting or data tools (e.g., Excel/Power BI or similar), and understanding of CSV and data integrity requirements.

• Lean/Six Sigma & Reliability:Demonstratedapplication of 5S, Standard Work, Kaizen, FMEA/RCM, and root-cause tools to improve uptime, energy intensity, and maintenance effectiveness; Green Belt or equivalent experience is beneficial.

• Regulatory & EHS: Solid understanding of GMP, HPRA/FDA expectations for utilities, Health & Safety regulations, and environmental compliance; experience preparing for and supporting audits/inspections.

• Soft Skills: Strong analytical and problem-solving ability, clear written and verbal communication, stakeholder management, and the ability to work independently and in cross-functional teams with a focus on delivery and continuous improvement.

• Desirable: Experience with digital twins/energymodeling, vibration/condition-based monitoring, power quality analysis, or sterilizing-grade utility interfaces to process equipment.

Education

HETAC Level 8 (or equivalent) in mechanical, chemical, electrical, mechatronics, or pharmaceutical engineering, or a related engineering discipline. Advanced degree and/or certifications in reliability, energy management, or automation/CSV areadvantageous.