General Manager Engineering & Projects

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 stakeholders to ensure smooth execution of engineering and project activities.
• Lead, mentor, and develop the Engineering, Utilities, Maintenance, and Projects teams.

Mandatory Technical Expertise

1. Process Equipment – Sterile Injectables

• Aseptic liquid filling lines and vial filling systems.
• Filling line equipment from B+S, Bosch, Groninger, IMA, Tofflon, Optima, Truking, Steriline, or equivalent OEMs.
• Lyophilizers (freeze dryers), autoclaves, and terminal sterilizers.
• Manufacturing vessels, holding vessels, and associated process equipment.
• Equipment selection, technical evaluation, troubleshooting, maintenance, qualification, and performance improvement.

2. Utilities and Facility Systems

• HVAC systems, AHUs, cleanrooms, and environmental control systems.
• Purified Water (PW), Water for Injection (WFI), and clean/pure steam generation and distribution systems.
• Boilers, chillers, air compressors, and other critical plant utilities.
• Building Management System (BMS) and utility monitoring systems.

3. Projects, Qualification and Compliance

• Greenfield sterile injectable facility setup and brownfield expansion projects.
• Equipment erection, installation, commissioning, and qualification, including IQ/OQ/PQ.
• Engineering change control, calibration, preventive maintenance, and GMP documentation.
• Regulatory inspection readiness and engineering compliance.

Candidate Profile

• Bachelor's degree in Mechanical Engineering; relevant engineering qualifications preferred.
• 18–25+ years of experience in pharmaceutical engineering, with substantial exposure to sterile injectable manufacturing.
• Proven leadership experience in Engineering, Process Equipment, Utilities, Maintenance, and Projects at a senior management level.
• Demonstrated capability in managing sterile facility operations, major engineering projects, CAPEX, and cross-functional teams.
• Strong expertise in process equipment, clean utilities, HVAC systems, project execution, and equipment reliability.
• Sound understanding of aseptic manufacturing practices, cleanroom requirements, GMP compliance, and regulatory expectations.
• Excellent leadership, planning, budgeting, vendor management, and problem-solving skills.

Preferred: Experience in setting up or expanding sterile injectable manufacturing facilities and independently managing end-to-end engineering and project operations.