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Assistant Manager, Mechanical Engineering

Amneal Pharmaceuticals
5-8 Years
Ahmedabad, India
Early Applicant
  • Posted 2 months ago
  • Be among the first 10 applicants

Job Description

Job Description2. Preventive & Breakdown Maintenance3. Water & Steam System Compliance4. Compressed Air, Nitrogen & CO Systems5. Documentation & GMP Compliance6. Qualification, Validation & Revalidation Support7. Change Management & Projects8. Safety & EHS Compliance9. Technical & Professional Skills

  • 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.
  • 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.
  • 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.
  • Ensure reliable supply and quality of:
    • Compressor systems, dryers, filters and distribution headers.
  • Maintain and monitor:
    • Cylinder manifolds / bulk supply systems for nitrogen and CO.
  • Ensure compliance with:
    • Pressure safety, alarm systems and changeover arrangements.
  • Support risk mitigation related to:
  • Cross connections, wrong gas supply and pressure failures.
  • 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.
  • 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.
  • 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.
    • 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.
    • 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.

    More Info

    Job Type:
    Permanent Job
    Industry:
    Other
    Function:
    Pharmaceutical
    Employment Type:
    Full time

    Job ID: 146058465

    Last Updated: 18-08-2026 02:17:23 AM
    Homejobs in AhmedabadAssistant Manager, Mechanical Engineering

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