Utilities Engineer

Do you want to contribute directly to the production of high-quality medicines that reach over 140 countries, positively impacting global healthcare?NES Fircroft is seeking a highly experienced Senior Utilities Engineer to support the startup, qualification, and ongoing compliance of clean utility systems within a sterile GMP setting. This role is critical in ensuring that systems such as WFI, Purified Water, Clean Steam, HVAC, and compressed gases meet current regulatory standards and operate reliably.Length: 12 months (possibility of extension)Lead commissioning and qualification (IQ/OQ/PQ) of clean utility systems per ASTM E2500 and GAMP.Manage FAT/SAT and author URS, FS, and DDS documentation.Ensure validated status and maintenance of WFI, PW, and Clean Steam systems.Review P&IDs, layouts, and isometrics during early project phases for compliance.Assess technical documentation for regulatory and operational alignment.Support inspections (e.g., IGJ) and ensure utility system readiness.Lead or assist in investigations and CAPA implementation.Design sampling/testing strategies with defined alert/action limits.Develop SOPs, maintenance plans, and long-term reliability strategies.Maintain audit-ready technical documentation.Drive improvements in compliance, energy efficiency, and system performance.Candidate Profile:At least 4 years of experience in pharmaceutical or biotech GMP environments.Proven expertise in startup and qualification of WFI, PW, and Clean Steam systems.Strong understanding of regulatory expectations for clean utilities (IGJ, FDA, EMA).Experience supporting regulatory inspections and managing utility-related compliance activities.Strategic thinker with the ability to structure and lead complex technical programs.