Job Summary This role is for an Engineering Operations and Maintenance Manager, responsible for overseeing the operation, maintenance, and continuous improvement of critical utility and process systems—including mechanical equipment, HVAC, WFI, PW, steam, and instrumentation—across the facility. The position ensures regulatory compliance, safety adherence, and system reliability through robust preventive, predictive, and reliability-centered maintenance strategies. Key responsibilities include leading engineering projects, managing CAPEX budgets, coordinating with cross-functional departments, and ensuring timely execution of equipment modifications, calibrations, and validations. The role also focuses on energy conservation, cost optimization, and maintaining audit readiness through effective documentation and quality systems. " Roles & Responsibilities Oversee the operation and maintenance of critical engineering systems—including mechanical equipment, HVAC, WFI, PW, and steam—to ensure continuous availability and optimal performance. Ensure compliance with GMP, FDA, and local regulations by conducting internal audits, managing documentation, and implementing corrective and preventive actions using tools like Why-Why analysis, Kaizens, and Poka-yoke. Lead engineering projects from initiation to completion, including resource planning, budget estimation, vendor coordination, and timely execution of instrumentation modifications. Develop and monitor preventive maintenance schedules in SAP, execute calibrations as per SOPs, and improve maintenance practices to reduce equipment breakdowns. Coordinate with cross-functional departments such as SHE, QA, QC, Production, IT, and Finance to ensure seamless maintenance and utility service delivery. Drive energy efficiency and cost optimization by implementing conservation techniques, monitoring utility generation costs, and maintaining records of energy consumption. Mentor and train engineering teams on maintenance procedures, safety protocols, hazard identification, and compliance with work permit requirements. Prepare and execute equipment qualification and validation schedules—including URS, DQ, IQ, OQ, PQ—and ensure documentation accuracy through cross-functional collaboration. "