Maintenance Manager

Key Responsibilities Maintenance Strategy & Systems Own and execute the site maintenance strategy across preventive, predictive, breakdown, and corrective maintenance. Implement, manage, and continuously improve a Computerized Maintenance Management System (CMMS) — asset registers, work orders, PM schedules, spare-parts data, and complete maintenance history — to ensure full traceability and audit-readiness. Define, track, and report maintenance KPIs (equipment uptime, OEE, MTBF, MTTR, PM-schedule compliance, breakdown frequency) to leadership. Preventive & Predictive Maintenance Develop and maintain PM schedules for all production and utility equipment based on OEM recommendations, criticality, and reliability data. Introduce condition-based / predictive techniques (vibration analysis, thermography, etc.) for critical assets. Drive Total Productive Maintenance (TPM) and reliability-centred maintenance (RCM) practices on the shop floor. Equipment Reliability & Production Support Ensure maximum availability of manufacturing equipment to meet the production plan. Lead rapid breakdown response and structured root-cause analysis (RCA); drive permanent corrective actions to prevent recurrence. Partner with Production and Quality to minimise unplanned downtime and changeover losses. Utilities & Facilities Manage critical utilities essential to a controlled manufacturing environment: HVAC and cleanroom systems, compressed air, purified/DI water, process gases (e.g., nitrogen, Oxygen, Argon etc.), chilled water, electrical distribution, UPS, and DG Sets. Keep cleanroom parameters (temperature, humidity, differential pressure, particle counts) within qualified limits, in line with ISO standards Oversee facility upkeep and building services. Regulatory Compliance & Quality Ensure all maintenance and calibration activities comply with ISO 13485, FDA 21 CFR Part 820, EU MDR, and applicable GMP requirements. Manage equipment qualification and requalification (DQ/IQ/OQ/PQ) and maintain a robust calibration programme for all measuring and test equipment. Operate maintenance within the quality system — change control, CAPA, deviation handling — and maintain inspection- and audit-readiness at all times (internal audits, notified bodies, FDA). Energy & Asset Management Lead energy-efficiency and utility-optimisation initiatives to reduce consumption and operating cost. Manage the equipment asset lifecycle — installation and commissioning through upgrades, overhauls, and end-of-life replacement — optimising total cost of ownership. Spares, Budget & Vendor Management Manage the maintenance budget (opex and capex inputs), spare-parts inventory, and cost control. Manage AMCs, service contracts, and relationships with OEMs and external service providers. Support evaluation, procurement, installation, and commissioning of new equipment and capital projects. Safety (EHS) Champion a strong safety culture; ensure all maintenance work follows EHS standards — permit-to-work, lockout-tagout (LOTO), work-at-height, hot work, and contractor safety. Ensure statutory compliance for pressure vessels, lifting equipment, electrical safety, and other regulated assets. Team Leadership & Development Lead, mentor, and develop a team of maintenance engineers and technicians; build shift coverage and on-call capability. Set clear standards and objectives, manage performance, and grow technical capability across the team. Collaborate cross-functionally with Production, Quality/RA, Projects, Stores, and EHS. Qualifications & Experience Education: Bachelor’s degree (B.E./B. Tech) in Mechanical, Electrical, Mechatronics, or Instrumentation Engineering. A postgraduate qualification (M. Tech / MBA) is an advantage. Experience: 10–15 years of progressive maintenance and engineering experience in a similar regulated manufacturing industry — medical devices, pharmaceuticals, or a comparable GMP / cleanroom environment — including several years in a maintenance leadership or managerial role. Proven track record of managing maintenance in a cleanroom / controlled environment. Hands-on experience with equipment qualification (IQ/OQ/PQ), calibration systems, and regulatory audits. Technical Skills & Knowledge Strong grounding in preventive/predictive maintenance, TPM, RCM, and reliability engineering. Proficiency with CMMS platforms and maintenance data analysis. Sound understanding of cleanroom HVAC, utilities, and their qualification. Working knowledge of ISO 13485, 21 CFR Part 820, EU MDR, ISO 14644, and GMP. Working knowledge of ISO 50001 and ISO 50001 internal auditor certification would be an advantage. Familiarity with RCA tools (5-Why, Fishbone, FMEA) and Lean / 5S. Electrical, mechanical, PLC / automation, and instrumentation troubleshooting exposure. Behavioural Competencies Strong leadership and people-development skills. Ownership mindset with a bias for problem-solving and permanent fixes. Clear communicator who works effectively across functions. Data-driven decision-making and continuous-improvement orientation. Calm and structured under pressure; dependable in breakdown and crisis situations. Uncompromising on quality, compliance, and safety.