About this role
Experience
5–8 years of relevant experience in mechanical maintenance, preferably in an API/pharmaceutical manufacturing plant.
Job Overview
Responsible for ensuring reliable and safe operation of mechanical equipment and utility systems in the API manufacturing facility. The role involves preventive and breakdown maintenance, equipment troubleshooting, maintenance planning, documentation, and coordination with Production, QA, EHS, and other engineering functions while maintaining GMP and safety compliance.
Key Responsibilities
Execute and supervise preventive, predictive, and breakdown maintenance activities for API manufacturing equipment.
Maintain equipment such as:
Reactors and agitators
Centrifuges
ANFDs / Nutsche filters
Dryers
Blowers and vacuum systems
Pumps and compressors
Heat exchangers
Scrubbers
Solvent recovery systems
Gearboxes and mechanical seals
Utility equipment
Troubleshoot mechanical failures and minimize equipment downtime.
Prepare and execute preventive maintenance schedules based on equipment criticality.
Monitor equipment health and identify recurring failures through root-cause analysis.
Coordinate with Production for planned equipment shutdowns and maintenance activities.
Ensure maintenance work is performed safely using appropriate PTW, LOTO, PPE, and safety procedures.
Support installation, commissioning, modification, and qualification of new equipment.
Coordinate with contractors and external service providers for specialized maintenance activities.
Maintain adequate spare-parts inventory and coordinate with Stores/Purchase for critical spares.
Review equipment specifications, drawings, manuals, and maintenance requirements.
Participate in breakdown analysis, RCA, CAPA, change control, and risk assessment activities.
Ensure maintenance activities are properly documented in CMMS/logbooks and other applicable records.
Support GMP, regulatory, customer, and internal audits and ensure timely closure of observations.
Ensure maintenance activities comply with applicable GMP, EHS, engineering standards, and company SOPs.
Support qualification activities such as IQ/OQ for new or modified mechanical equipment.
Monitor maintenance KPIs such as equipment availability, MTBF, MTTR, breakdown frequency, and preventive-maintenance compliance.
Guide technicians and junior engineering personnel in troubleshooting and maintenance practices.
API / GMP Knowledge
Good understanding of cGMP requirements applicable to engineering and maintenance.
Knowledge of equipment qualification and engineering documentation.
Understanding of Good Documentation Practices and data integrity.
Familiarity with change control, deviation, CAPA, and maintenance-related investigations.
Awareness of hazardous-area requirements and safe handling of solvents and chemicals.
Knowledge of ATEX/IECEx or hazardous-area equipment requirements is an advantage.
Technical Skills
Strong knowledge of pumps, compressors, gearboxes, agitators, mechanical seals, bearings, valves, and piping systems.
Knowledge of steam, chilled water, cooling water, compressed air, nitrogen, vacuum, and HVAC-related mechanical systems.
Ability to read P&IDs, equipment drawings, GA drawings, and mechanical specifications.
Knowledge of alignment, vibration, lubrication, and condition monitoring.
Familiarity with CMMS/SAP PM or equivalent maintenance-management systems.
Basic knowledge of fabrication, welding, piping, and utility systems.
Qualification
B.E./B.Tech/Diploma in Mechanical Engineering from a recognized institution.
Key Competencies
Mechanical troubleshooting and problem-solving
Maintenance planning and execution
Equipment reliability
GMP and safety compliance
Team coordination
Vendor/contractor management