09 Oct
|
Immacule Lifesciences
|
Nalagarh
09 Oct
Immacule Lifesciences
Nalagarh
Job Purpose
To lead and oversee Engineering, Process Equipment, Utilities, Maintenance, and Projects for a sterile injectable manufacturing facility, ensuring equipment reliability, operational excellence, regulatory compliance, and successful execution of infrastructure development and capacity expansion projects.
Key Responsibilities
• Lead overall Engineering, Process Equipment, Utilities, Maintenance, and Projects operations for the sterile injectable manufacturing facility.
• Ensure optimal performance, reliability, and uptime of process equipment, manufacturing systems, and critical utilities.
• Oversee the installation, commissioning, qualification, validation, and maintenance of process equipment and utility systems.
• Manage preventive, predictive, and breakdown maintenance, including troubleshooting, root cause analysis (RCA), and corrective and preventive actions (CAPA).
• Lead greenfield and brownfield projects, facility development, plant modifications, capacity expansion, and equipment upgradation.
• Review and finalize equipment specifications, URS, plant layouts,
PFDs, P&IDs;, engineering designs, and project estimates.
• Manage project planning, CAPEX budgeting, cost control, procurement coordination, vendor selection, and execution timelines.
• Coordinate Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), equipment erection, commissioning, and performance verification.
• Ensure compliance with cGMP, WHO-GMP, USFDA, EU-GMP, EHS, and applicable regulatory requirements.
• Maintain engineering documentation, equipment qualification records, calibration records, preventive maintenance schedules, and audit readiness.
• Monitor critical spare inventory, equipment performance, utility consumption, and maintenance expenditure.
• Drive energy conservation, cost optimization, equipment reliability, productivity enhancement, and continuous improvement initiatives.
• Collaborate with QA, Production, Validation, EHS, Procurement, and other stakehol
📌 General Manager Engineering (Nalagarh)
🏢 Immacule Lifesciences
📍 Nalagarh