31 Jul
|
Immacule Lifesciences
|
Himachal Pradesh
31 Jul
Immacule Lifesciences
Himachal Pradesh
Job DescriptionPurpose NLead Engineering, Utilities, Maintenance, and Projects to ensure reliable plant operations, regulatory compliance, and continuous improvement in a sterile injectable manufacturing facility. NKey Responsibilitiesn N Lead Engineering, Utilities, Maintenance, and Projects. N Ensure maximum uptime of process equipment and utilities. N Manage preventive, predictive, and breakdown maintenance. N Handle equipment breakdowns through RCA and CAPA. N Lead equipment installation, commissioning, qualification, validation, and calibration. N Execute Greenfield/Brownfield projects, plant modifications, and capacity expansion. N Review plant layouts, PFDs, P&IDs;, engineering designs, and project estimates. N Manage project planning, budgeting, procurement, vendor development, and execution. N Ensure compliance with cGMP, WHO, USFDA, EU GMP, EHS, and Data Integrity requirements. N Support regulatory audits and engineering documentation. N Monitor critical spare inventory and utility performance. N Drive cost optimization, energy conservation, reliability, and productivity improvements.
N Lead and develop the Engineering team while providing cross-functional support. NnTechnical Requirements Nn Solid experiencein sterile injectable manufacturing. N Sound knowledge of aseptic practices, cleanroom behavior, GMP documentation, and engineering compliance. N Ability to independently manage engineering operations and projects in a regulated pharmaceutical environment. NnMandatory Equipment Exposure Nn Filling Lines (B+S, Bosch, Groninger, IMA, Tofflon, Optima, Truking, Steriline, etc.) N Lyophilizersn Autoclaves N Manufacturing & HoldingVessels N HVAC, PW/WFI Systems, Clean Steam N Boilers, Chillers, Air Compressors, BMS and other plant utilities. NnQualification & Experience Nn B.E./B.Tech (Mechanical/Electrical/Instrumentation or related discipline). N 18–25+ years of pharmaceutical engineering experience with significant exposure to USFDA/EU GMP-approved sterile injectable facilities. N
📌 General Manager Engineering (Sterile Facility) (Himachal Pradesh)
🏢 Immacule Lifesciences
📍 Himachal Pradesh