Key Roles & Responsibilities
Mechanical Maintenance Activities
- Perform preventive, predictive, corrective, and breakdown maintenance of manufacturing, packing, utility, and facility equipment.
- Inspect equipment regularly to identify wear, damage, leakage, vibration, and abnormal operating conditions.
- Attend equipment breakdowns and restore operations within defined timelines.
- Ensure equipment availability to meet production schedules.
- Support annual maintenance shutdown activities.
Manufacturing Equipment Maintenance
- Maintain equipment associated with:
- Dispensing
- Granulation
- Compression
- Coating
- Capsule Filling
- Bottle Packing
- Blister Packing
- Cartoning Operations
- Perform alignment, lubrication, replacement, and adjustment of machine components.
- Troubleshoot mechanical failures affecting manufacturing performance.
- Ensure optimal equipment efficiency and reliability.
Utility Equipment Maintenance
- Maintain utility systems including:
- Air Compressors
- Chillers
- Cooling Towers
- Pumps
- Vacuum Systems
- Water Systems
- Steam Distribution Systems
- HVAC Mechanical Equipment
- Ensure uninterrupted utility support to manufacturing operations.
- Monitor utility equipment performance and operational efficiency.
Equipment Inspection & Troubleshooting
- Conduct routine inspections and condition monitoring.
- Perform root cause analysis for equipment failures and recurring breakdowns.
- Identify corrective and preventive actions to improve equipment reliability.
- Analyze vibration, noise, temperature, and performance abnormalities.
- Implement corrective actions to reduce downtime.
Preventive Maintenance Management
- Execute maintenance activities as per approved preventive maintenance schedules.
- Complete maintenance tasks within planned timelines.
- Ensure compliance with maintenance SOPs and checklists.
- Maintain PM records and equipment history cards.
- Verify machine readiness before production start-up.
Installation & Commissioning
- Assist in installation, commissioning, and startup of new equipment and facilities.
- Support Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) activities.
- Participate in equipment trials and process validation activities.
- Assist engineering and projects teams in expansion initiatives.
- Verify mechanical integrity of newly installed equipment.
Qualification & Validation Support
- Support IQ, OQ, and PQ activities for manufacturing and utility equipment.
- Participate in equipment requalification activities.
- Provide engineering support for validation protocols and reports.
- Support change controls and modification projects.
- Assist during technology transfer and process improvement initiatives.
Documentation & Compliance
- Maintain maintenance logbooks, work orders, and equipment history records.
- Record maintenance activities accurately in maintenance management systems.
- Follow Good Documentation Practices (GDP).
- Maintain calibration and maintenance records where applicable.
- Ensure proper closure of maintenance work orders.
cGMP & Regulatory Compliance
- Ensure all maintenance activities comply with cGMP requirements.
- Follow approved SOPs, engineering standards, and maintenance procedures.
- Support audit readiness and regulatory inspections.
- Participate in internal audits, customer audits, and regulatory audits.
- Support compliance with Data Integrity and quality requirements.
Spare Parts & Inventory Management
- Monitor availability of critical mechanical spare parts.
- Raise spare requirements and maintain inventory records.
- Verify quality and specifications of received spare parts.
- Ensure optimum inventory levels to support maintenance activities.
- Reduce equipment downtime through proper spare management.
Safety, Health & Environment (EHS)
- Follow all engineering safety procedures and EHS guidelines.
- Comply with Permit-to-Work (PTW) and Lockout-Tagout (LOTO) systems.
- Use prescribed Personal Protective Equipment (PPE).
- Report unsafe conditions, near misses, and incidents immediately.
- Participate in safety observations, audits, and emergency drills.
Continuous Improvement
- Participate in TPM, Lean Manufacturing, Kaizen, and Operational Excellence initiatives.
- Support projects focused on reliability improvement and downtime reduction.
- Identify opportunities for cost savings and process improvements.
- Recommend equipment modifications to improve productivity and safety.
- Drive initiatives to improve Mean Time Between Failures (MTBF) and equipment performance.
Team Coordination
- Coordinate with Production, QA, QC, Engineering, Utilities, Validation, and Project teams.
- Support external vendors and contractors during maintenance activities.
- Ensure effective communication during shift handovers.
- Assist in training operators on proper equipment operation and basic maintenance practices.
Educational Qualification
- B.E./B.Tech in Mechanical Engineering, Production Engineering, Industrial Engineering, or equivalent.
Experience
- 3-6 years for entry-level Team Member roles.
- Experience in pharmaceutical, API, OSD, FMCG, food processing, or regulated manufacturing industries preferred.
- Exposure to manufacturing equipment maintenance and utility systems is desirable.
Required Knowledge & Skills
Technical Skills
- Knowledge of mechanical maintenance practices.
- Understanding of pharmaceutical manufacturing and packaging equipment.
- Knowledge of pumps, compressors, gearboxes, motors, bearings, valves, and rotating equipment.
- Understanding of utility systems and facility equipment.
- Ability to read engineering drawings, P&IDs, GA drawings, and equipment manuals.
- Basic knowledge of preventive and predictive maintenance techniques.
- Understanding of cGMP, GDP, and pharmaceutical compliance requirements.
- Basic knowledge of TPM, Reliability Engineering, and Root Cause Analysis
