Purpose

Lead Engineering, Utilities, Maintenance, and Projects to ensure reliable plant operations, regulatory compliance, and continuous improvement in a sterile injectable manufacturing facility.

Key Responsibilities

- Lead Engineering, Utilities, Maintenance, and Projects.
- Ensure maximum uptime of process equipment and utilities.
- Manage preventive, predictive, and breakdown maintenance.
- Handle equipment breakdowns through RCA and CAPA.
- Lead equipment installation, commissioning, qualification, validation, and calibration.
- Execute Greenfield/Brownfield projects, plant modifications, and capacity expansion.
- Review plant layouts, PFDs, P&IDs;, engineering designs, and project estimates.
- Manage project planning, budgeting, procurement, vendor development, and execution.
- Ensure compliance with cGMP, WHO, USFDA, EU GMP, EHS, and Data Integrity requirements.
- Support regulatory audits and engineering documentation.
- Monitor critical spare inventory and utility performance.
- Drive cost optimization, energy conservation, reliability, and productivity improvements.




- Lead and develop the Engineering team while providing cross-functional support.

Technical Requirements

- Solid experience in sterile injectable manufacturing.
- Sound knowledge of aseptic practices, cleanroom behavior, GMP documentation, and engineering compliance.
- Ability to independently manage engineering operations and projects in a regulated pharmaceutical environment.

Mandatory Equipment Exposure

- Filling Lines (B+S, Bosch, Groninger, IMA, Tofflon, Optima, Truking, Steriline, etc.)
- Lyophilizers
- Autoclaves
- Manufacturing & Holding Vessels
- HVAC, PW/WFI Systems, Clean Steam
- Boilers, Chillers, Air Compressors, BMS and other plant utilities.

Qualification & Experience

- B.E./B.Tech (Mechanical/Electrical/Instrumentation or related discipline).
- 18–25+ years of pharmaceutical engineering experience with significant exposure to USFDA/EU GMP-approved sterile injectable facilities.

📌 General Manager Engineering (Sterile facility) (Nalagarh)
🏢 Immacule Lifesciences
📍 Nalagarh