General Manager Engineering (Sterile facility)

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 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).
• 1825+ years of pharmaceutical engineering experience with significant exposure to USFDA/EU GMP-approved sterile injectable facilities.