Utilities Engineer

Role Overview:

The Utilities Engineer is responsible for the safe, compliant, and efficient design, operation, maintenance, and optimisation of plant utilities supporting pharmaceutical manufacturing operations. The role covers the full lifecycle of utilities systems, from initial concept/design through installation, qualification, operation, and ongoing improvement. All systems must meet regulatory, quality, and business requirements.

Key Responsibilities:

• Lead or contribute to the conceptual and detailed design of pharmaceutical utility systems (e.g., WFI, Purified Water, Clean Steam, HVAC, Compressed Air, Nitrogen).
• Prepare and review engineering drawings, P&IDs, specifications, data sheets, calculations, and technical documentation for new utility systems or system upgrades.
• Ensure all utility designs comply with relevant regulatory requirements (cGMP, FDA, EMA, EHS, etc.) and industry standards.
• Collaborate with project managers, process engineers, architects, and external engineering consultants on utility design and integration with facility layouts.
• Oversee day-to-day operation, monitoring, troubleshooting, and optimisation of utilities following design intent and performance requirements.
• Plan and carry out preventive, predictive, and corrective maintenance on utility equipment per cGMP and safety standards.
• Oversee third-party contractors and vendors for utilities installation, commissioning, design verification, and validation.
• Support utilities commissioning, qualification, and validation activities (IQ/OQ/PQ), including preparation and review of documentation.
• Prepare and update as-built drawings and required GMP documentation for utility systems.
• Participate in root cause analysis for utilities-related design deviations, non-conformances, and equipment failures.
• Recommend and implement system upgrades and energy efficiency improvements, supporting the full project cycle from design to handover.
• Maintain accurate maintenance and calibration records in the CMMS.
• Act as a technical subject matter expert on utility system design during regulatory inspections and audits.
• Provide technical mentorship or design review support to junior engineers and other stakeholders.

Key Requirements:

• Bachelor’s degree in Mechanical, Chemical, Electrical Engineering or related field (required).
• Minimum 5 years’ experience as a Utilities/Facilities Engineer in the pharmaceutical, biotechnology, or regulated process industries, including hands-on experience in the design of utility systems.
• Demonstrated experience in preparing utility system designs (conceptual, basic, and detailed) and engineering documentation (e.g., P&IDs, equipment layouts, data sheets, design calculations).
• Strong knowledge of pharmaceutical utilities systems (water systems, steam, gases, HVAC) and associated regulatory requirements.
• Experience in system commissioning, qualification, and validation (IQ/OQ/PQ) within GMP environments.
• Familiarity with software tools for engineering design (e.g., AutoCAD, Revit, or equivalent).
• Experience working with or managing external engineering design consultants and contractors