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Engineering - Head Pharmaceutical background

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Onsite

Engineering - Head Pharmaceutical background

Agio Pharmaceuticals

Engineering - Head Pharmaceutical background

Skills

ComplianceRegulatory Compliance

23 days ago

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Important information


Contract type:

Permanent

Location:

Pune, Maharashtra, India

Work mode:

Onsite

Published on:

3 October 2026

What they need


Role & 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)

  1. 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/equipments 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.

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