Job Description Engineering & Maintenance Manager (Pharmaceutical Manufacturing)

Position

Engineering & Maintenance Manager

Department

Engineering & Maintenance

Job Summary

The Engineering & Maintenance Manager is responsible for ensuring the smooth operation, maintenance, and reliability of all manufacturing equipment, utilities, and facility systems in compliance with GMP, regulatory, and safety requirements. The role includes preventive maintenance, utility management, engineering projects, equipment qualification, and continuous improvement to maximize plant efficiency and minimize downtime.

Key Responsibilities

- Plan, implement, and monitor preventive, predictive, and breakdown maintenance for production and packaging equipment.
- Manage pharmaceutical utilities including HVAC, Water Systems (PW/WFI), Boilers, Chillers, Air Compressors, DG Sets, Electrical Panels, and AHUs.
- Lead equipment installation, commissioning, qualification (IQ/OQ/PQ), and validation support.
- Ensure compliance with GMP, cGMP, EHS, and statutory regulations.
- Coordinate with Production, QA, QC, Validation, and Projects for uninterrupted manufacturing operations.
- Prepare and maintain SOPs, maintenance schedules, equipment history cards, calibration records,



and engineering documentation.
- Monitor spare parts inventory, vendor performance, AMC contracts, and engineering budgets.
- Conduct root cause analysis (RCA), CAPA implementation, and continuous improvement initiatives to enhance equipment reliability.
- Lead facility expansion, equipment upgrades, and engineering projects.
- Develop, train, and manage the engineering and maintenance team while promoting a culture of safety and operational excellence.

Qualification

- B.E./B.Tech in Mechanical, Electrical, Instrumentation, or Industrial Engineering.

Experience

- 8–12 years of experience in Engineering & Maintenance within a Pharmaceutical Manufacturing Unit.
- Experience in OSD, Injectable, Semi-solid, or Liquid manufacturing facilities is preferred.

Key Skills

- Preventive & Breakdown Maintenance
- Pharmaceutical Utilities Management
- Equipment Qualification (IQ/OQ/PQ)
- HVAC, Water Systems & Electrical Maintenance
- GMP/cGMP & Regulatory Compliance
- Validation & Calibration Support
- Root Cause Analysis (RCA) & CAPA
- Vendor & Project Management
- SAP/CMMS Maintenance Systems (preferred)
- Team Leadership & Continuous Improvement

📌 Engineering & Maintenance Manager (Pharmaceutical Manufacturing) (Gujarat)
🏢 ALVIO PHARMACEUTICALS
📍 Gujarat