01 Aug
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Immacule Lifesciences
|
Himachal Pradesh
01 Aug
Immacule Lifesciences
Himachal Pradesh
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 Strong 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 setting. Mandatory Equipment Exposure Filling Lines (BS, 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) (Himachal Pradesh)
🏢 Immacule Lifesciences
📍 Himachal Pradesh