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 theSenior Manager Utilities this role executes day-to-day technical ownership continuous improvement and lifecycle management of utilities through the application ofAI-enabled and digital strategieslean transformation and disciplinedfinancial 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: 37 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.