Role Objective / Major Purpose of the Job This role Senior Manager oversees preventive, predictive, and corrective maintenance programs, drives equipment reliability and operational excellence, and ensures compliance with current Good Manufacturing Practice (cGMP), environmental, health, and safety (EHS), and regulatory requirements. Principal Tasks & Responsibilities • Develop and execute maintenance strategies aligned with business and manufacturing objectives. • Lead preventive, predictive, and breakdown maintenance programs for API manufacturing equipment, utilities, and facility infrastructure. • Ensure high equipment availability and reliability while minimizing unplanned downtime. • Oversee maintenance of reactors, centrifuges, dryers, filters, mills, blenders, HVAC systems, chillers, boilers, cooling towers, compressors, water systems, and other utility equipment. • Drive reliability engineering initiatives using Root Cause Analysis (RCA), Failure Mode and Effects Analysis (FMEA), Reliability-Centered Maintenance (RCM), and predictive maintenance techniques. • Plan and manage annual maintenance shutdowns, plant turnarounds, and equipment overhauls. • Manage maintenance budgets, capital expenditure (CapEx), operating expenditure (OpEx), spare parts inventory, and vendor contracts. • Develop maintenance KPIs and drive continuous improvement using Lean Manufacturing and Total Productive Maintenance (TPM) principles. • Strong understanding of API manufacturing equipment, plant utilities, and facility maintenance. RO, DM, and PW generation systems (where applicable) Pumps, piping, valves, and mechanical equipment Preventive Maintenance (PM) procedures User Requirement Specifications (URS) CAPA documentation Lead installation, commissioning, qualification, and validation of new equipment and utility systems. Ensure compliance with cGMP, US FDA, EU GMP, WHO GMP, and other applicable regulatory requirements. Key Skills & Competencies Functional / Technical: • Preventive, Predictive, and Corrective Maintenance Reliability Engineering (RCM, RCA, FMEA) API Manufacturing Equipment Utility Systems (HVAC, Boilers, Chillers, Cooling Towers, Air Compressors) Clean Utility Systems (Purified Water, Water for Injection, Clean Steam) Mechanical, Electrical, and Instrumentation Maintenance CMMS (SAP PM, ) Lean Manufacturing and Total Productive Maintenance (TPM) Capital Project Management Equipment Qualification and Validation Support Behavioural: • Team Player, Problem Solving, Strategic Agility Professional / Educational Qualifications Master's degree in Engineering or Business Administration. Experience with SAP PM. Experience supporting regulatory inspections by agencies such as the FDA, EMA, MHRA, or equivalent authorities. Experience 12–18 years of progressive experience in maintenance engineering within the pharmaceutical API/chemical.
