Executive Plant Maintenance Injectable Manufacturing

Immacule Life Sciences; Solan; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Immacule Life Sciences is seeking a maintenance engineer to handle preventive and corrective maintenance for sterile injectable manufacturing equipment and critical utility systems. You will coordinate with production and QA to minimize downtime and ensure regulatory compliance across USFDA, EU-GMP, and WHO-GMP standards.

The role requires hands-on experience with vial filling lines, lyophilizers, autoclaves, HVAC, and pharmaceutical utilities, along with strong documentation and CAPA support.

Qualifications

• 3–7 years of experience in maintenance of sterile injectable / parenteral manufacturing facilities.

Responsibilities

• Perform preventive, predictive, and breakdown maintenance of injectable manufacturing equipment such as vial filling machines, ampoule filling machines, lyophilizers, autoclaves, washing machines, depyrogenation tunnels, capping machines, and isolators/RABS.
• Ensure smooth operation of utility systems including HVAC, purified water (PW), WFI, clean steam, compressed air, vacuum, and nitrogen systems.
• Troubleshoot mechanical, electrical, pneumatic, and instrumentation-related issues to minimize downtime.
• Execute and document maintenance activities as per SOPs, GMP, and data integrity requirements.
• Participate in equipment qualification activities (IQ/OQ/PQ), calibration coordination, and validation support.
• Maintain maintenance records, equipment history cards, logbooks, and spare parts inventory.
• Coordinate with Production, QA, QC, and Validation departments for planned shutdowns and maintenance schedules.
• Support deviation investigation, CAPA implementation, change control, and audit readiness.
• Ensure compliance with USFDA, EU-GMP, WHO-GMP, and other regulatory requirements.
• Monitor contractor activities and ensure adherence to EHS and permit-to-work systems.
• Identify opportunities for reliability improvement, energy saving, and maintenance optimization.

Skills

Preventive maintenance

Predictive maintenance

Electrical

Pneumatic

Instrumentation

GMP compliance

Education

B.E./B.Tech or Diploma in Mechanical / Electrical / Instrumentation Engineering

Tools

Filling lines

Lyophilizers

Autoclaves

HVAC

Pharmaceutical utility systems

Job description

Role & responsibilities

• Perform preventive, predictive, and breakdown maintenance of injectable manufacturing equipment such as vial filling machines, ampoule filling machines, lyophilizers, autoclaves, washing machines, depyrogenation tunnels, capping machines, and isolators/RABS.


• Ensure smooth operation of utility systems including HVAC, purified water (PW), WFI, clean steam, compressed air, vacuum, and nitrogen systems.


• Troubleshoot mechanical, electrical, pneumatic, and instrumentation-related issues to minimize downtime.


• Execute and document maintenance activities as per SOPs, GMP, and data integrity requirements.


• Participate in equipment qualification activities (IQ/OQ/PQ), calibration coordination, and validation support.


• Maintain maintenance records, equipment history cards, logbooks, and spare parts inventory.


• Coordinate with Production, QA, QC, and Validation departments for planned shutdowns and maintenance schedules.


• Support deviation investigation, CAPA implementation, change control, and audit readiness.


• Ensure compliance with USFDA, EU-GMP, WHO-GMP, and other regulatory requirements.


• Monitor contractor activities and ensure adherence to EHS and permit-to-work systems.


• Identify opportunities for reliability improvement, energy saving, and maintenance optimization.

Preferred candidate profile

• Education: B.E./B.Tech or Diploma in Mechanical / Electrical / Instrumentation Engineering.


• Experience: 37 years in maintenance of sterile injectable / parenteral manufacturing facilities.


• Hands-on experience with filling lines, lyophilizers, autoclaves, HVAC, and pharmaceutical utility systems preferred.