Assistant Manager, Mechanical Engineering

Amneal Pharmaceuticals; Ahmedabad; On-site; INR 600,000 - 800,000; Full time

Job summary

A pharmaceutical company in Ahmedabad is seeking a qualified engineer to oversee the operation and monitoring of essential water systems. The role requires ensuring compliance with manufacturing standards and managing utility operations, including preventive maintenance. Candidates should have 5–8 years of experience in pharmaceutical utilities, with a degree in Mechanical, Electrical, or Chemical Engineering. Strong knowledge of GMP and hands-on troubleshooting skills for equipment are essential.

Qualifications

• 5–8 years of relevant experience in pharmaceutical water systems and utilities.
• Experience in parenteral or sterile manufacturing facility required.

Responsibilities

• Operation and monitoring of water system.
• Ensure compliance with quality attributes for aseptic manufacturing.
• Coordinate with production and QA for utility availability.
• Prepare and execute preventive maintenance plans.
• Support investigations related to OOS/OOT excursions.

Skills

Troubleshooting capability for pumps

Good communication skills

Knowledge of GMP

Sanitization practices

Education

B.E. / B.Tech / Diploma in Mechanical, Electrical, Instrumentation or Chemical Engineering

Job description

Job Description

• 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.
• Ensure 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.