About this role
Experience
6–10 years of relevant experience in API / Pharmaceutical manufacturing
Qualification
B.E. / B.Tech / Diploma in Mechanical Engineering
Experience in API/pharmaceutical manufacturing is preferred.
Job Purpose
To lead and manage maintenance activities for API manufacturing facilities, process equipment, and plant utilities, ensuring high equipment availability, minimum breakdowns, safe operations, GMP compliance, and timely execution of preventive and predictive maintenance programs.
Key Responsibilities
Maintenance Management
Plan and supervise preventive, predictive, breakdown, and corrective maintenance activities.
Ensure maximum availability and reliability of critical manufacturing equipment and utilities.
Monitor equipment performance, identify recurring failures, and implement effective corrective actions.
Review maintenance schedules and ensure timely completion of planned maintenance activities.
Analyze equipment downtime and develop action plans for improvement.
API Process Equipment
Manage maintenance of reactors, agitators, centrifuges, dryers, filters, pumps, vacuum systems, heat exchangers, scrubbers, and other API process equipment.
Ensure proper maintenance of mechanical systems, rotating equipment, and associated utilities.
Support equipment installation, commissioning, modification, and qualification activities.
Utility Maintenance
Oversee maintenance of critical utilities such as:
Chillers and cooling towers
Boilers and steam systems
HVAC systems
Compressed air
Nitrogen systems
Vacuum systems
Water systems
ETP/STP and other relevant utilities
GMP & Compliance
Ensure all maintenance activities comply with GMP, SOPs, EHS requirements, and site procedures.
Maintain equipment history, maintenance records, checklists, and work orders.
Support internal, customer, regulatory, and GMP audits.
Ensure timely investigation and closure of engineering-related deviations, CAPA, and change controls.
Ensure proper implementation of LOTO, work permits, and other safety practices.
Team Management
Lead and guide maintenance engineers, technicians, and contract manpower.
Allocate manpower and maintenance activities according to plant priorities.
Train team members on equipment maintenance, safety, GMP, and troubleshooting.
Monitor team performance and ensure effective shift/round-the-clock maintenance support.
Spare Parts & Cost Control
Identify and maintain adequate inventory of critical engineering spares.
Review spare-part requirements and coordinate procurement with the purchase team.
Control maintenance costs without compromising equipment reliability or safety.
Evaluate vendors and service providers for maintenance-related activities.
Reliability Improvement
Conduct RCA (Root Cause Analysis) for major and repetitive equipment failures.
Drive reliability improvement initiatives and reduce unplanned downtime.
Identify opportunities for predictive maintenance and condition monitoring.
Implement engineering improvements and modifications to improve equipment performance.
Key Skills
Strong knowledge of API/pharmaceutical manufacturing equipment and utilities.
Good understanding of mechanical maintenance and rotating equipment.
Knowledge of GMP, EHS, CAPA, deviation, change control, and audit requirements.
Experience with SAP/CMMS maintenance systems.
Strong troubleshooting and RCA skills.
Good team leadership and people-management skills.
Strong planning, coordination, and communication skills.
Ability to handle emergency breakdowns and work under pressure.
Key Performance Indicators (KPIs)
Preventive maintenance compliance.
Reduction in equipment breakdowns and downtime.
Critical equipment availability and reliability.
Reduction in repeat equipment failures.
Timely closure of maintenance work orders.
Maintenance cost optimization.
GMP/EHS compliance.