1. Operation & Monitoring of Water system • Ensure continuous and compliant operation of: • Pretreatment, PW, WFI, pure steam, compressed air and gas distribution systems. • Monitor critical parameters such as: • Flow, pressure, temperature, conductivity, TOC, differential pressure and system alarms. • Ensure utilities meet required quality attributes for aseptic / parenteral manufacturing. • Coordinate with production and QA for utility availability and usage planning. • Maintain required spares/inventory of engineering department. 2. Preventive & Breakdown Maintenance • Prepare, review and execute preventive maintenance plans for all utility systems. • Attend and resolve breakdowns with minimum downtime and root cause analysis. • Ensure availability of critical spares for all utility equipment (pumps, valves, instruments, sensors, filters, etc.). • Supervise and guide technicians and contract service personnel. 3. Water & Steam System Compliance • Ensure: • Sanitization / sterilization cycles (thermal or chemical) are performed as per approved SOPs. • Loop integrity, slope, dead-leg control and proper circulation. • Review and support: • Trending of conductivity, TOC and microbiological results. • Support investigations related to: • OOS / OOT / excursions of PW, WFI and pure steam systems. 4. Compressed Air, Nitrogen & CO₂ Systems • Ensure reliable supply and quality of: • Compressor systems, dryers, filters and distribution headers. • Maintain and monitor: • Cylinder manifolds / bulk supply systems for nitrogen and CO₂. • Ensure compliance with: • Pressure safety, alarm systems and changeover arrangements. • Support risk mitigation related to: • Cross connections, wrong gas supply and pressure failures. 5. Documentation & GMP Compliance • Prepare, review and maintain: • SOPs, checklists, logbooks and Operation, maintenance records. • Ensure: • All activities are performed as per GMP and site procedures. • Support internal, customer and regulatory audits related to utility systems. • Ensure proper documentation of: • Deviations, CAPA, change controls and risk assessments. 6. Qualification, Validation & Revalidation Support • Support preparation and execution of: • DQ, IQ, OQ and PQ activities for new and existing utility systems. • Support protocol execution for: • PW, WFI, pure steam, compressed air and gas distribution systems. • Support periodic requalification and performance monitoring activities. • Coordinate with QA and validation teams during execution. 7. Change Management & Projects • Actively participate in: • Utility related modifications, revamping and capacity enhancement projects. • Prepare and support: • Engineering inputs for MOC, URS, layouts, P&ID reviews and equipment selection. • Coordinate with: • Vendors, consultants, contractors and internal stakeholders. • Ensure: • Proper installation, commissioning and handover of new systems. 8. Safety & EHS Compliance • Ensure compliance with: • Electrical, mechanical, pressure vessel and chemical handling safety requirements. • Ensure proper implementation of: • Permit-to-work, LOTO and confined space procedures. • Promote safe working practices among technicians and contractors. 9. Technical & Professional Skills • Strong working knowledge of: • PW, WFI, pure steam and loop design concepts • Sanitization / sterilization practices • Microbiological and chemical control of water systems • Good understanding of: • GMP, data integrity and regulatory expectations for utilities • Experience in: • Qualification / validation documentation • Deviation, CAPA and change control processes • Hands-on troubleshooting capability for: • Pumps, valves, heat exchangers, instruments and automation systems • Good communication, coordination and documentation skills. • B.E. / B.Tech / Diploma in Mechanical, Electrical, Instrumentation or Chemical Engineering. • 5–8 years of relevant experience in pharmaceutical water system & utilities, preferably in parenteral / sterile manufacturing facility.