Role & responsibilities
- Manufacturing Process Equipments Maintenance & Troubleshooting
- Perform operation, preventive, and breakdown maintenance of manufacturing process equipment, including:
- Granulation lines (RMG, FBD, Mill, Blender)
- Dispensing units and material handling systems
- Coating machines (Auto coaters)
- Compression machines
- Track & Trace systems
- Primary packaging areas (Blister, Strip, Bottle lines etc.)
- Secondary packaging areas (Cartoner, BPU, Case packer, Serialization equipment etc.)
- Ensure minimum downtime and high equipment availability through timely troubleshooting and root cause analysis. Maintain shift wise report and update MTBF and MTTR accordingly.
- Support continuous manufacturing operations with prompt response to breakdowns.
- Handle modifications, upgrades, and retrofits of manufacturing equipment as per approved change controls.
- Tracking of PM schedule and completing the PM activity within schedule online in E log software.
- Calibration Management
- Ensure compliance with calibration schedules for instruments used in manufacturing, warehouse and quality Control.
- Review calibration results and support investigation of out-of-tolerance (OOT) conditions.
- Initiate and close calibration-related deviations, RCA, and CAPA in collaboration with QA.
- EHS & Statutory Compliance
- Ensure adherence to safety norms, statutory guidelines, and site EHS policies.
- Implement and monitor LOTO practices, permit-to-work systems, and use of electrical PPE.
- Participate in electrical safety audits, EHS inspections, and incident investigations.
- Maintain compliance of earthing, lightning protection, and electrical safety testing.
- Regulatory & QMS Documentation
- Actively participate in QMS activities related to engineering and manufacturing, including:
- Change Control (CC)
- Deviation and incident handling
- CAPA implementation and effectiveness review
- Prepare, review, and maintain SOPs, logbooks, and technical documentation for process equipment systems.
- Support regulatory audits and inspections (USFDA, WHO, MHRA, EU) by providing technical inputs and maintaining documentation.
- Qualification & Validation Support
- Support IQ/OQ/PQ and requalification activities for manufacturing equipment, utilities, and control systems.
- Coordinate with QA and Validation teams to ensure compliance with validated state requirements.
- Continuous Improvement
- Drive improvement initiatives related to equipment reliability, energy efficiency, and maintenance optimization.
- Analyse recurring failures and implement preventive measures.
- Support digitization and predictive maintenance initiatives.
Preferred candidate profile
Candidate should have hands on experience in Plant Maintenance i.e Packing, Manufacturing area, Engineering QMS, Equipment qualification etc.