Role & responsibilities

Key Responsibilities

1. Maintenance and Asset Management

Preventive and Predictive Maintenance:

Design and execute annual maintenance schedule for all machines and equipment in the plant.

Breakdown Analysis:

Implement Root cause analysis (RCA) and CAPA for repetitive failures for minimize downtime.

Spare Parts Management

Optimize inventory level for critical spares to balance cost and operational readiness.

Building Management System (BMS)

Responsible for BMS (Building Management System)

2. Utility & Facility Management

HVAC System

Oversee complex HVAC system to maintain pressure differentials, temperature, and humidity as per standards.

Water System

Manage Purified Water (PW), Water for Injection (WFI), and Pure Steam (PS) System, ensuring consistent chemical and microbiological compliance.

Power and Energy

Manager DG Sets, boilers, air compressors and chillers. Lead energy conservation initiatives to reduce the plants carbon footprint.

3. Projects and Capital Expenditure

Facility Management

Lead the design, installation and commissioning of new machines/equipment’s or facility upgrades.

Vendor Management

Evaluate technical details, manage contractors,



and ensure project delivery within timelines and budgets.

4. Regulatory Compliance and Quality

Validation & Qualification:

Oversee DQ, IQ, OQ and PQ for all equipment and utilities.

Audit Readiness:

Act as the primary technical lead during regulatory inspections. Ensure all logbooks, SOPs, and maintenance records are ‘ALCOA’ compliant.

Team Development

Mentor multidisciplinary teams of engineers and technicians, fostering a culture of continuous improvement.

Regulatory Compliance & EHS Compliance

Responsible for relative Regulatory Compliance and EHS Compliance.

Master's or Bachelor's degree in Engineering (Mechanical or Electrical)

Experience Minimum 15-20 years of experience in Engineering / Maintenance within the pharmaceutical industry preferably formulation plant. Experience with Cleanroom validations and Process water system. At least 5 years in capacity of HOD.

Deep knowledge of cGMP, Valuable Engineering Practices and 21 CFR Part 11. Hands on experience across OSD, Liquids and Sterile Injectable dosage forms.

Strong analytical and trouble shooting skills. Leadership and negotiation skills.

📌 Engineering - Manager Pharmaceutical background only (Pune)
🏢 Agio Pharmaceuticals
📍 Pune