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 CO₂.
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.
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.
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.
