Job Purpose
To ensure reliable operation, maintenance, calibration, and troubleshooting of instrumentation, automation, process, and utility systems in a USFDA-approved sterile injectable manufacturing facility.
Key Responsibilities
- Execute preventive, predictive, and breakdown maintenance of instrumentation, automation, process, and utility equipment.
- Troubleshoot PLC, SCADA, HMI, BMS, EMS, HVAC, and utility-related issues.
- Attend breakdowns, perform repairs, and ensure minimum equipment downtime.
- Coordinate and execute calibration activities as per approved schedules.
- Support installation, commissioning, qualification, and validation of new equipment and systems.
- Maintain preventive maintenance, calibration, and breakdown records.
- Monitor spare inventory and ensure availability of critical spares.
- Ensure compliance with cGMP, Data Integrity, EHS, SOPs, and Permit-to-Work requirements.
- Participate in deviation investigations, CAPA, change controls, and root cause analysis.
- Support regulatory audits and inspections.
- Coordinate with Production, QA, QC, Validation, and Engineering teams for smooth plant operations.
- Perform other responsibilities assigned by the Reporting Manager.
Qualification
- B.E./B.Tech/Diploma in Instrumentation, Electronics & Instrumentation, Electrical & Instrumentation, or Automation Engineering.
Experience
- 7-10 years of relevant experience in Instrumentation & Automation.
- Mandatory experience in a USFDA-approved Sterile Injectable Manufacturing Facility.
- Hands-on experience in PLC, SCADA, HMI, BMS, EMS, HVAC, calibration, and utility systems.
- Exposure to qualification, validation, and regulatory audit requirements.
Mandatory Requirement
Only candidates with experience in USFDA-approved Sterile Injectable Manufacturing Facilities will be considered.
