Engineering - Head Pharmaceutical background only

Agio Pharmaceuticals; Pune District; On-site; INR 4,200,000 - 6,800,000; Full time

Job summary

Agio Pharmaceuticals in Pune, India, seeks a seasoned Head of Maintenance and Engineering to lead plant upkeep, reliability programs, and capital projects for a GMP pharmaceutical facility. You will oversee utilities, BMS, and regulatory compliance while guiding a multidisciplinary team.

You will drive preventive maintenance, RCA/CAPA, and vendor management, ensuring high equipment availability and adherence to 21 CFR Part 11 and ALCOA records.

Qualifications

• Master's or Bachelor's degree in Mechanical or Electrical Engineering.
• 15–20 years of engineering/maintenance experience in the pharmaceutical industry, preferably in a formulation plant.
• Experience with cleanroom validations and process water systems.
• At least 5 years in a leadership role (HOD).
• Strong knowledge of cGMP, GEP and 21 CFR Part 11.

Responsibilities

• Design and execute the annual maintenance schedule for all plant machines and equipment.
• Lead Root Cause Analysis (RCA) and CAPA for repetitive failures to minimize downtime.
• Oversee Spare Parts management to balance cost and operational readiness.
• Head Building Management System (BMS) operations and utility systems (HVAC, PW, WFI, PS).
• Drive vendor management, project delivery, and regulatory/EHS compliance.

Skills

Leadership

Analytical skills

Troubleshooting

Team development

Negotiation

Regulatory awareness

Education

Master's or Bachelor's in Mechanical or Electrical Engineering

Job description

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, Good 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.