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.