12 Aug
|
Gadgeon Medical Systems
|
India
12 Aug
Gadgeon Medical Systems
India
Job Title: Maintenance Engineer
Department: Maintenance
Reports to: Senior Manager- Operations
Location: Angamaly, Kochi
Job Summary
The Maintenance Engineer (MEP) responsible for the upkeep and reliability of the plant's Mechanical, Electrical, and Plumbing (MEP) infrastructure and production support utilities, and acting as the factory's designated Safety Officer, driving statutory compliance and a safe working environment across the facility. The role is critical to maintaining equipment qualification status (IQ/OQ/PQ), uninterrupted compliant manufacturing operations, and the plant's overall EHS compliance posture.
Key Responsibilities
Equipment & MEP Maintenance
- Plan and execute preventive maintenance (PM) schedules for production machinery, assembly equipment, packaging lines, and utilities (DG, HVAC etc.).
- Own end-to-end Mechanical, Electrical, and Plumbing (MEP) upkeep: HVAC and AHUs, electrical distribution (panels, DG sets, UPS, transformers), fire hydrant and sprinkler systems, plumbing and drainage systems.
- Attend to breakdowns promptly to minimize production downtime; carry out root cause analysis for recurring failures.
- Maintain spare parts inventory and coordinate procurement of critical spares.
- Plan and oversee MEP related capex/repair projects, AMCs, contractor work, and utility upgrades.
Safety Officer Duties
- Act as the facility's designated Safety Officer under applicable Factories Act / state safety rules, ensuring statutory compliance.
- Develop, implement, and periodically review standard safety procedures across the plant.
- Conduct safety inductions, mock drills (fire, evacuation), and periodic safety training for employees.
- Investigate incidents, near-misses, and accidents; drive root cause analysis and corrective/preventive actions.
- Maintain statutory registers, safety permits (hot work, confined space, work-at-height), and liaise with factory inspectorate and other regulatory bodies.
- Enforce use of PPE, machine guarding,
and safe handling of machines.
- Lead the plant's fire safety and emergency preparedness programs, including fire extinguisher/hydrant testing and evacuation planning.
- Track and report safety KPIs (near-misses, audit findings) to plant leadership.
Cleanroom & Utility Systems
- Maintain and monitor cleanroom HVAC systems, differential pressure, temperature, and humidity controls per classification requirements (ISO Class 8).
- Ensure calibration and maintenance of utility systems.
- Support environmental monitoring programs in coordination with Quality teams.
Regulatory & Documentation Compliance
- Maintain equipment maintenance records, logbooks, and history cards as per ISO 13485 requirements.
- Support equipment qualification activities (IQ/OQ/PQ) and re-qualification after major repairs or modifications.
- Ensure calibration schedules for instruments and gauges are followed and documented; coordinate with metrology/calibration teams.
- Assist in audits (internal, ISO, customer) by providing maintenance documentation and evidence of compliance.
Process & Reliability Improvement
- Implement predictive maintenance techniques where applicable to reduce unplanned downtime.
- Analyze equipment performance data and recommend improvements.
- Support new equipment installation, commissioning, and validation.
Electrical & Fire Safety Compliance
- Maintain compliance with electrical, mechanical, and fire safety standards applicable to the facility, including statutory inspections and certifications.
- Coordinate third-party safety audits (electrical safety audit, fire audit) and ensure timely closure of findings.
Team Coordination
- Supervise and guide maintenance technicians; ensure timely completion of assigned tasks.
- Coordinate with Supply chain, Production, Quality and Administration teams to minimize disruption during maintenance activities.
- Liaise with external vendors/OEMs for specialized repairs, AMC (annual maintenance contracts), and spare part sourcing.
Required Qualifications
- Bachelor’s degree in Mechanical, Electrical, Electronics, or Instrumentation Engineering.
- Diploma in Industrial Safety / Certified Safety Officer qualification (as recognized under applicable state Factories Rules) is required for the Safety Officer charter.
- 5–8 years of maintenance experience, preferably in medical device, pharmaceutical, or regulated manufacturing industries, with prior exposure to MEP systems and factory safety functions.
- Experience maintaining cleanroom facilities and utility systems is highly desirable.
Required Skills & Competencies
- Strong understanding of mechanical, electrical, plumbing (MEP), pneumatic, and HVAC systems.
- Sound knowledge of factory safety legislation (Factories Act / state rules), permit-to-work systems, and fire safety norms.
- Familiarity with ISO 13485 and GMP maintenance documentation requirements.
- Strong analytical and troubleshooting skills; ability to work under pressure during breakdowns and safety incidents.
Pay: ₹550,000.00 - ₹750,000.00 per year
Application Question(s):
- Current monthly take home salary
- Expected Monthly take home salary
- Do you have robust understanding of mechanical, electrical, plumbing (MEP), pneumatic, and HVAC systems.
- Do you have exposure to factory safety functions.
- Do you have maintenance experience, in medical device, pharmaceutical, or highly regulated manufacturing industries
Work Location: In person
📌 Maintenance Engineer (India)
🏢 Gadgeon Medical Systems
📍 India