Role Purpose
Lead the engineering and execution of a greenfield biosimilars manufacturing facility, covering conceptual design, basic and detailed engineering, procurement, construction, commissioning, qualification, and handover to operations.
The role will have overall engineering ownership for facility, process systems, utilities, equipment, HVAC, automation, electrical, civil/structural, and infrastructure, ensuring the project meets approved scope, schedule, CAPEX, GMP, EHS, quality, and regulatory requirements.

Key Responsibilities:

1. Engineering Project Leadership
• Lead all engineering activities for the greenfield biosimilars facility from concept design through commissioning and handover.
• Develop the engineering execution strategy, project organization, deliverables, schedules, and resource requirements.
• Establish and manage engineering scope, budget, schedule, interfaces, risks, and technical deliverables.
• Coordinate multidisciplinary engineering teams and ensure timely resolution of technical issues.
• Lead technical reviews, design reviews, HAZOP/HAZID,



constructability reviews, value engineering, and design optimization.

2. Facility & Process Engineering
• Drive development of facility layouts, process flows, material/personnel flows, zoning, segregation, and cleanroom concepts.
• Ensure facility design supports biosimilar manufacturing requirements, including:• Upstream processing
• Downstream processing
• Buffer/media preparation
• Formulation
• Drug substance/drug product areas, as applicable
• Sampling and dispensing
• Cold rooms/freezers
• Warehousing
• QC laboratories

• Review and approve URS, FRS, process descriptions, PFDs, P&IDs;, equipment specifications, and engineering drawings.
• Ensure design incorporates appropriate future expansion and capacity requirements.

3. Utilities & Infrastructure
Provide engineering oversight for critical GMP and non-GMP utilities, including:
• Purified Water / WFI systems
• Clean steam
• Process gase

📌 Associate General Manager, Project (Ahmedabad)
🏢 Amneal
📍 Ahmedabad