Assistant Manager, Mechanical Engineering

Amneal India; Gujarat; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Amneal India is seeking a skilled professional to lead operation and monitoring of water systems in its pharmaceutical manufacturing facilities. The role focuses on ensuring continuous, compliant operation of pretreatment, PW, WFI, pure steam, compressed air, and gas distribution networks.

You will coordinate with production and QA, maintain spares, execute preventive maintenance, handle breakdowns, and support validation, change control, and GMP compliance across utility systems.

Qualifications

• Experience in operating and maintaining utility systems in pharma/regulated environments.
• Knowledge of GMP, data integrity and regulatory expectations for utilities.
• Ability to coordinate with production, QA and engineering teams to ensure system availability.

Responsibilities

• Operate and monitor water, PW/WFI, steam, compressed air and gas distribution systems to ensure continuous, compliant operation.
• Prepare, review and execute preventive maintenance plans for utility assets and equipment.
• Attend and resolve breakdowns with root cause analysis and minimal downtime.
• Support sanitization/sterilization cycles and loop integrity checks per SOPs.
• Collaborate on deviations, CAPA and change controls related to utility systems.
• Maintain proper documentation of deviations, change controls and risk assessments.
• Coordinate qualification/validation activities (DQ/IQ/OQ/PQ) for utility systems.
• Support audits and investigations related to water and gas systems.

Skills

Water systems

Maintenance planning

Troubleshooting

Documentation

Safety compliance

QA coordination

Tools

Pumps

Valves

Instruments

Automation

Job 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 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 & Professional 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

• Good communication, coordination and documentation skills.