Nitika Pharmaceutical Specialities Pvt. Ltd | Full time
Industry: Pharmaceutical Manufacturing
Department: Engineering – Maintenance
Location: Butibori Manufacturing Plant
Experience: 4–7 Years
Qualification: B.E./B.Tech in Mechanical Engineering
Position Summary
We are seeking an experienced Mechanical Engineer to join our Maintenance team at our pharmaceutical manufacturing facility inButibori. The ideal candidate will be responsible for ensuring the reliability,availability, and efficient operation of production equipment and utilitysystems through preventive, predictive, and breakdown maintenance. The rolerequires strict adherence to cGMP, EHS, and regulatory requirements whilesupporting uninterrupted manufacturing operations.
Key Responsibilities
- Plan, schedule, and executepreventive, predictive, and breakdown maintenance activities for productionequipment and utility systems.
- Ensure maximum equipmentavailability with minimum downtime to support production targets.
- Diagnose and troubleshootmechanical failures, implementing timely corrective actions to restore equipment functionality.
- Maintain and servicepharmaceutical manufacturing equipment, including reactors, granulators, blenders, dryers, centrifuges, compression machines, coating machines, and packaging equipment.
- Oversee maintenance of utilitysystems such as HVAC, boilers, chillers, compressed air systems, steam systems, purified water systems, vacuum systems, pumps, and piping networks.
- Prepare and maintain preventive maintenance schedules, SOPs, equipment history records, and maintenance documentation.
- Coordinate with Production, Quality Assurance, Engineering, Validation, and other cross-functional teams to ensure equipment readiness and smooth operations.
- Monitor spare parts inventory and coordinate procurement of critical mechanical spares to avoid maintenance delays.
- Supervise contractors and ensure all maintenance work is performed in compliance with safety, GMP, and company procedures.
- Support equipment qualification, validation, calibration activities, plant shutdowns, and annual maintenance planning.
- Ensure compliance with cGMP, EHS, statutory, and regulatory requirements during all maintenance activities.
- Conduct root cause analysis (RCA) of recurring equipment failures and implement effective Corrective and Preventive Actions (CAPA) to improve equipment reliability.
- Maintain accurate maintenance records and support internal, customer, and regulatory audits.
- Strong knowledge of pharmaceutical manufacturing equipment and utility systems.
- Hands‑on experience inpreventive, predictive, and breakdown maintenance.
- Sound understanding of HVAC, boilers, chillers, compressors, pumps, piping systems, and other utility equipment.
- Ability to read and interpret P&IDs, mechanical drawings, engineering layouts, and equipment manuals.
- Good understanding of GMP, cGMP, EHS practices, and regulatory compliance requirements.
- Strong troubleshooting, analytical, and root cause analysis skills.
- Experience with SAP PM, CMMS, or other maintenance management systems is preferred.
- Proficiency in MS Office;knowledge of AutoCAD will be an added advantage.
- Good communication, coordination, and team management skills.
Educational Qualification
- B.E./B.Tech in MechanicalEngineering.
Preferred Experience
- 4–7 years of relevant experience in the Maintenance Department of a pharmaceutical or regulated manufacturing facility.
- Exposure to formulation, API,or OSD manufacturing plants will be an added advantage.