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USV in Vadodara, a state-of-the-art Formulations facility, seeks a senior equipment maintenance lead to oversee preventive, predictive, and breakdown maintenance of pharmaceutical process equipment.
You will drive reliability improvement, ensure cGMP compliance, manage shutdowns and projects with QA and Validation, optimize costs, document in SAP, and lead a skilled maintenance team to sustain high OEE.
Position Reports to : HOD - Site Engineering
Plant Details : State-of-the-art Formulations (Oral Solid Dosage) Manufacturing Facility. This high-technology plant features fully automated processes, with no manual intervention, setting a new standard for precision, efficiency, and quality in pharmaceutical manufacturing. The plant is equipped with an ASRS facility, closed loop manufacturing operation, end to end automated packing lines, integrated MES system, paperless QC and BMS controlled HVAC system.
1. Equipment Maintenance: Lead preventive, predictive, and breakdown maintenance of pharmaceutical process equipment, including granulators, FBDs, tablet presses, coating machines, and packing equipment.
2. Reliability & Performance: Improve equipment reliability, availability, and OEE through root cause analysis (RCA), failure analysis, and continuous improvement initiatives.
3. GMP & Compliance: Ensure maintenance activities comply with cGMP, safety standards, data integrity requirements, and applicable regulatory guidelines.
4. Shutdown & Project Management: Plan and execute equipment overhauls, shutdowns, equipment installation, commissioning, and qualification support in coordination with Production, QA, and Validation teams.
5. Cost & Resource Optimization: Manage maintenance budgets, spare parts inventory, manpower deployment, and external service providers to optimize maintenance costs.
6. Documentation & Systems: Ensure timely completion of maintenance records, SOPs, work orders, and maintenance activities in the SAP.
7. Team Leadership: Lead and develop the maintenance team, strengthen technical capabilities, implement reliability improvement programs, and promote a strong safety and continuous improvement culture.