10 Aug
|
Amneal
|
Ahmedabad
Description
1. Operation & Monitoring of Water system
- Ensure continuous and compliant operation of:
- Pretreatment, PW, WFI, pure steam, compressed air and gas distribution systems.
- Monitor critical parameters such as:
- Flow, pressure, temperature, conductivity, TOC, differential pressure and system alarms.
- Ensure utilities meet required quality attributes for aseptic / parenteral manufacturing.
- Coordinate with production and QA for utility availability and usage planning.
- Maintain required spares/inventory of engineering department.
2. Preventive & Breakdown Maintenance
- Prepare, review and execute preventive maintenance plans for all utility systems.
- Attend and resolve breakdowns with minimum downtime and root cause analysis.
- Ensure availability of critical spares for all utility equipment (pumps, valves, instruments, sensors, filters, etc.).
- Supervise and guide technicians and contract service personnel.
3. Water & Steam System Compliance
- Ensure:
- Sanitization / sterilization cycles (thermal or chemical) are performed as per approved SOPs.
- Loop integrity,
slope, dead-leg control and proper circulation.
- Review and support:
- Trending of conductivity, TOC and microbiological results.
- Support investigations related to:
- OOS / OOT / excursions of PW, WFI and pure steam systems.
4. Compressed Air, Nitrogen & CO₂ Systems
- Ensure reliable supply and quality of:
- Compressor systems, dryers, filters and distribution headers.
- Maintain and monitor:
- Cylinder manifolds / bulk supply systems for nitrogen and CO₂.
- Ensure compliance with:
- Pressure safety, alarm systems and changeover arrangements.
- Support risk mitigation related to:
- Cross connections, wrong gas supply and pressure failures.
5. Documentation & GMP Compliance
- Prepare, review and maintain:
- SOPs, checklists, logbooks and Operation, maintenance records.
- Ensure:
- All activities are performed as per GMP and site procedures.
- Support internal, customer and regulatory
📌 Assistant Manager, Mechanical Engineering (Ahmedabad)
🏢 Amneal
📍 Ahmedabad