Assistant Manager, Mechanical Engineering at Amneal… · Ahmedabad…

Job Title: Assistant Manager – Water system & Utilities (Operations & Maintenance – Parenteral Unit) Department: Project & Engineering Reporting to: Manager – Project & Engineering Location: Parenteral Manufacturing Facility

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

Qualifications

• 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.