Engineering - Manager Pharmaceutical background only

Agio Pharmaceuticals; Pune District; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Agio Pharmaceuticals in Pune seeks a senior Maintenance and Facilities leader to drive asset management, utility systems, and project delivery across the pharmaceutical plant. You will design maintenance programs, supervise regulatory compliance, and mentor engineering teams.

The ideal candidate has 15–20 years in pharma engineering, hands-on with cGMP, 21 CFR Part 11, and cleanroom validations; minimum 5 years as Head of Department.

Qualifications

• Bachelor’s or Master’s in Engineering (Mechanical or Electrical).
• 15–20 years of experience in Engineering/Maintenance within the pharmaceutical industry (formulation).
• Experience with Cleanroom validations and Process water systems (PW, WFI, PS).
• At least 5 years in a leadership role (HOD or equivalent).
• Strong knowledge of cGMP, Good Engineering Practices and 21 CFR Part 11.

Responsibilities

• Design and execute annual maintenance schedule for plant machines and equipment.
• Lead RCA and CAPA for repetitive failures to minimize downtime.
• Optimize spare parts inventory to balance cost and uptime.
• Oversee Building Management System (BMS) and utility systems (HVAC, PW, WFI, PS).
• Lead design, installation, and commissioning of new machines/equipment or facility upgrades.
• Manage vendors, contractors, and ensure project delivery within timelines and budgets.
• Ensure regulatory compliance and EHS alignment; support audit readiness.

Skills

Leadership

Negotiation

Analytical thinking

Troubleshooting

Regulatory compliance

Education

Engineering (Mechanical/Electrical)

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.