Mechanical Engineer with 22+ years of experience in the pharmaceutical sector, specializing in formulation, biotechnology API, vaccines, sterile injectables, and FMCG.Excellence in Leading Engineering Functions in operations & maintenance, projects, utility management, and facility management with Indian and multinational organizations like Johnson & Johnson, Serum Institute, Cipla, Biomerieux, Emcure, and Genesys Biologics.Involved in and experienced with USFDA, MHRA, EU, TGA, WHO, and various customer-specific regulatory audits, from plant design to audit compliance.Operation & Maintenance: Management of entire plant engineering operations, maintaining cGMP state of the plant, handling major breakdowns for process equipment, water systems, HVAC, BMS & EMS, and utilities systems. Monitoring efficiency & improvement, effective utilization, spare parts management, and consumption in terms of cost and energy savings.Preparation of Capex/Opex cost optimization, vendor management & construction operations, and ensuring statutory compliances for safety, environmental, and equipment standards.Project Management: Experience in completing Greenfield and Brownfield projects from conceptualization to validation, driving manufacturing sites toward long-term business objectives for all regulated markets.Executing projects from start to finish, including detailed design, layouts, automation implementation, planning/budgeting, FS, MS Project, execution and commissioning, technical evaluation, risk identification, and control within the timeline to meet global quality standards with appropriate good documentation practices and process simplification.Expertise in organizing staffing, employee management, and controlling various sites with strong leadership, implementing systems, innovation, integrity, training & development skills, and motivation for organizational growth.