Assistant Manager, Mechanical Engineering

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 800,000 - 1,000,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Ahmedabad, India, seeks a Water Systems Engineer to oversee the operation of pretreatment, PW, WFI, pure steam and gas distribution, ensuring continuous, compliant performance in a sterile manufacturing environment.

You will monitor key parameters, coordinate with production and QA, plan preventive maintenance, manage spares, support investigations, and ensure GMP documentation and validation activities related to utility systems.

Qualifications

• Strong working knowledge of PW, WFI, pure steam and loop design concepts.
• GMP, data integrity and regulatory expectations for utilities.
• Experience in qualification/validation documentation and change control processes.
• Hands-on troubleshooting of pumps, valves, heat exchangers and automation systems.

Responsibilities

• Operate and monitor pretreatment, PW, WFI, pure steam, compressed air and gas distribution systems.
• Monitor critical parameters and system alarms.
• Coordinate with production and QA for utility availability and usage planning.
• Maintain required spares/inventory of engineering department.
• Prepare, review and execute preventive maintenance plans for all utility systems.
• Attend and resolve breakdowns with minimum downtime and root cause analysis.
• Ensure sanitization/sterilization cycles per SOPs and loop integrity.
• Review conductivity/TOC and microbiological trends.
• Support investigations related to OOS/OOT/excursions of PW, WFI and pure steam systems.
• Coordinate with QA and validation teams during execution of qualification workloads.

Skills

PW/WFI knowledge

Sterilization knowledge

GMP compliance

Documentation skills

Troubleshooting pumps

Automation familiarity

QA coordination

Safety awareness

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.