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 audits related to utility systems.

- Ensure proper documentation of:

- Deviations, CAPA, change controls and risk assessments.

6. Qualification, Validation & Revalidation Support

- Support preparation and execution of:

- DQ, IQ, OQ and PQ activities for new and existing utility systems.

- Support protocol execution for:

- PW, WFI, pure steam, compressed air and gas distribution systems.

- Support periodic requalification and performance monitoring activities.

- Coordinate with QA and validation teams during execution.

7. Change Management & Projects

- Actively participate in:

- Utility related modifications, revamping and capacity enhancement projects.

- Prepare and support:

- Engineering inputs for MOC, URS, layouts, P&ID; reviews and equipment selection.

- Coordinate with:

- Vendors, consultants, contractors and internal stakeholders.

- Ensure:

- Proper installation, commissioning and handover of new systems.

8. Safety & EHS Compliance

- Ensure compliance with:

- Electrical, mechanical, pressure vessel and chemical handling safety requirements.

- Ensure proper implementation of:

- Permit-to-work, LOTO and confined space procedures.

- Promote safe working practices among technicians and contractors.

9. Technical & Skilled Skills

- Strong working knowledge of:

- PW, WFI, pure steam and loop design concepts

- Sanitization / sterilization practices

- Microbiological and chemical control of water systems

- Good understanding of:

- GMP, data integrity and regulatory expectations for utilities

- Experience in:

- Qualification / validation documentation

- Deviation, CAPA and change control processes

- Hands-on troubleshooting capability for:

- Pumps, valves, heat exchangers, instruments and automation systems

- Positive communication, coordination and documentation skills.

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

- 5–8 years of relevant experience in pharmaceutical water system & utilities, preferably in parenteral / sterile manufacturing facility.

📌 Assistant Manager, Mechanical Engineering (India)
🏢 Amneal Pharmaceuticals
📍 India