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 c GMP, 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). 18–25+ years of pharmaceutical engineering experience with significant exposure to USFDA/EU GMP-approved sterile injectable facilities.