The Utility Engineer is responsible for the 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
Operate and optimize utility 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 and maintain data pipelines and dashboards from CMMS, BMS/EMS, and historians; apply advanced analytics and support machine learning models for predictive maintenance, 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 and maintain URS, DQ/IQ/OQ/PQ documentation, periodic reviews, alarm/limit management, and criticality assessments.
Ensure utilities remain in validated state and compliant with GMP, HPRA/FDA, EHS, and environmental requirements.
Quality & EHS
Maintain utility 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).
Identify and 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
Maintain SOPs, 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 to maintain compliant 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, clean compressed 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
Proficiency with URS, DQ/IQ/OQ/PQ, calibration/metrology, alarm philosophy, and maintaining validated 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
Demonstrated application 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/energy modeling, 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 are advantageous.
17-Oct-****
30-Oct-****
Our mission is to build an inclusive and equitable environment.
We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process.
We welcome and consider applications from all qualified candidates, regardless of characteristics.
We offer reasonable adjustments/accommodations to help all candidates to perform at their best.
If you have a need for any adjustments/accommodations, please complete the section in the application form.
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