12 Aug
|
Immacule Lifesciences
|
Solan
12 Aug
Immacule Lifesciences
Solan
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 Responsibilities
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- 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.n
nTechnical Requirements
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- Strong experience in 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 workplace.n
nMandatory Equipment Exposure
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- Filling Lines (B+S, Bosch, Groninger, IMA, Tofflon, Optima, Truking, Steriline, etc.)n
- Lyophilizersn
- Autoclavesn
- Manufacturing & Holding Vesselsn
- HVAC, PW/WFI Systems, Clean Steamn
- Boilers, Chillers, Air Compressors, BMS and other plant utilities.n
nQualification & Experience
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- B.E./B.Tech (Mechanical/Electrical/Instrumentation or related discipline).n
- 18–25+ years of pharmaceutica
📌 General Manager Engineering (Solan)
🏢 Immacule Lifesciences
📍 Solan