Associate General Manager - Engineering API Projects

About the job

Role & responsibilities 1. Project Planning & Execution • Lead end-to-end project management for new API manufacturing facilities, plant expansions, and capacity enhancement projects. • Develop and manage project schedules, budgets, timelines, and resource plans using tools such as Primavera or MS Project. • Coordinate with consultants, architects, and EPC contractors for basic and detailed engineering, procurement, and construction activities. • Drive installation, commissioning, and qualification (IQ/OQ/PQ) of process, utility, and ancillary systems. • Ensure on-time delivery of projects within approved budgets and scope. 2. Engineering & Technical Oversight • Review and approve Process Flow Diagrams (PFDs), Piping & Instrumentation Diagrams (P&IDs), equipment data sheets, and layout drawings. • Ensure engineering design adheres to cGMP, USFDA, EMA, MHRA, and WHO standards. • Support technology transfer, process scale-up, and equipment selection in coordination with R&D and Manufacturing teams. • Provide technical leadership in areas such as utilities (WFI, clean steam, HVAC, chillers, compressed air) and cleanroom design. 3. Cross-Functional Coordination • Collaborate closely with internal teams including Production, Quality Assurance, Quality Control, Regulatory Affairs, EHS, and Procurement for smooth execution. • Work with Finance and Procurement for cost estimation, vendor selection, contract negotiation, and budget tracking. • Lead site-based project teams, ensuring effective communication, accountability, and goal alignment. • Build strong relationships with external partners, consultants, and suppliers to ensure best-in-class project delivery. 4. Compliance, Quality & Safety • Ensure strict adherence to EHS (Environment, Health & Safety) and Quality Management standards throughout project execution. • Conduct Hazard and Operability Studies (HAZOP), risk assessments, and implement mitigation strategies. • Ensure all activities comply with statutory, local, and international regulatory requirements. • Support readiness for regulatory audits and inspections related to project and facility setup. 5. Reporting & Documentation • Prepare comprehensive project reports, including progress updates, risk analysis, and deviation reports, for senior management. • Maintain accurate documentation as per GMP and project management protocols. • Track project performance against defined KPIs and milestones, recommending corrective actions as needed. • Present updates in management review meetings and provide visibility into project health and financial status. Experience: • Minimum 15+ years of experience in API or bulk drug project management, preferably with leading pharmaceutical companies. • Proven experience in executing Greenfield and Brownfield projects from concept to commissioning. • Exposure to multi-location projects (India and/or international sites). • Strong understanding of GMP facility design, process equipment, utilities, and HVAC systems. • Familiarity with international regulatory guidelines USFDA, EMA, MHRA, WHO. • Proficiency in project management tools such as Primavera, MS Project, and AutoCAD.