Assistant Manager, Mechanical Engineering
Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 41d ago
Undisclosed5–8 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
1. Operation Monitoring of Water system
- Ensure continuous and compliant operation of:
- Pretreatment, PW, WFI, pure steam, compressed air and gas distribution systems.
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- Monitor critical parameters such as:
- Flow, pressure, temperature, conductivity, TOC, differential pressure and system alarms.
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- 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 maintece 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.
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- Review and support:
- Trending of conductivity, TOC and microbiological results.
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- Support investigations related to:
- OOS / OOT / excursions of PW, WFI and pure steam systems.
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- Ensure reliable supply and quality of:
- Compressor systems, dryers, filters and distribution headers.
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- Maintain and monitor:
- Cylinder manifolds / bulk supply systems for nitrogen and CO .
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- Ensure compliance with:
- Pressure safety, alarm systems and changeover arrangements.
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- Support risk mitigation related to:
- Cross connections, wrong gas supply and pressure failures.
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- Prepare, review and maintain:
- SOPs, checklists, logbooks and Operation, maintece records.
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- Ensure:
- All activities are performed as per GMP and site procedures.
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- 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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- Support preparation and execution of:
- DQ, IQ, OQ and PQ activities for new and existing utility systems.
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- Support protocol execution for:
- PW, WFI, pure steam, compressed air and gas distribution systems.
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- 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.
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- Prepare and support:
- Engineering inputs for MOC, URS, layouts, PID reviews and equipment selection.
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- Coordinate with:
- Vendors, consultants, contractors and internal stakeholders.
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- Ensure:
- Proper installation, commissioning and handover of new systems.
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- Ensure compliance with:
- Electrical, mechanical, pressure vessel and chemical handling safety requirements.
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- Ensure proper implementation of:
- Permit-to-work, LOTO and confined space procedures.
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- 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
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- Good understanding of:
- GMP, data integrity and regulatory expectations for utilities
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- Experience in:
- Qualification / validation documentation
- Deviation, CAPA and change control processes
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- Hands-on troubleshooting capability for:
- Pumps, valves, heat exchangers, instruments and automation systems
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- Good 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.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Heat ExchangersAutomationBreakdown Maintenancedesign conceptsEquipment SelectionauditsChemical Handlingchemical engineeringCAPAChange ControlehsChange ManagementAutomation systemsEhs ComplianceCompressorcompliance
About Amneal Pharmaceuticals
Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
About
Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.
Industries
PharmaBiotechnologyClinical Research
Employee ratings
1,455 reviews
4.2/ 5
Culture
4.0
Career growth
3.5
Work-life
4.2
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