Assistant Manager, Mechanical Engineering

2. Preventive & Breakdown Maintenance 3. Water & Steam System Compliance 4. Compressed Air, Nitrogen & CO₂ Systems 5. Documentation & GMP Compliance 6. Qualification, Validation & Revalidation Support 7. Change Management & Projects 8. Safety & EHS Compliance 9. 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 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.

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.