Associate General Manager, Project & Engineering

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 gases and compressed air
- HVAC and cleanroom systems
- Chilled water and cooling systems
- Boilers and hot-water systems
- Nitrogen and other specialty gases
- Electrical distribution and backup power
- Building management systems
- Effluent and waste-treatment systems
- Fire protection systems
- Plant and site infrastructure

4. Equipment Engineering & Procurement

- Lead selection, specification, technical evaluation, and procurement of major process and utility equipment.
- Review vendor proposals and participate in technical bid evaluations .
- Manage equipment design reviews, FAT/SAT , vendor documentation, and installation requirements.
- Ensure equipment selection meets GMP, maintainability, safety, reliability, and lifecycle-cost requirements.
- Coordinate integration of single-use and stainless-steel technologies , as applicable.

5. EPC / EPCM & Contractor Management

- Manage EPC/EPCM consultants, engineering contractors, construction contractors, and equipment vendors.
- Review engineering deliverables and ensure compliance with approved design standards.
- Monitor contractor performance against scope, schedule, quality, and cost .
- Lead technical and commercial discussions related to engineering changes and contractor claims.
- Ensure effective interface management between engineering disciplines and construction teams.

6. Automation & Digital Systems

- Provide engineering leadership for BMS, EMS, SCADA, DCS/PLC, process automation, and facility monitoring systems .
- Ensure appropriate integration between process equipment and site automation systems.
- Coordinate with IT/CSV teams for computerized-system requirements and GMP compliance.
- Support implementation of data-integrity and electronic-record requirements.

7. Construction, Commissioning & Qualification

- Provide engineering leadership throughout construction and installation.
- Ensure construction activities comply with approved drawings, specifications, GMP requirements, and EHS standards.
- Lead construction punch-list closure and technical issue resolution.
- Coordinate commissioning, qualification, and validation activities with CQV, QA, Engineering, and Operations.
- Ensure readiness of systems for IQ/OQ/PQ and process qualification , as applicable.
- Drive engineering handover and preparation of final documentation/as-built drawings.

8. GMP & Regulatory Compliance

- Ensure engineering design complies with applicable cGMP, GEP, GxP, EHS, and regulatory requirements .
- Incorporate relevant requirements from US FDA, EMA, MHRA, WHO, PIC/S, ISPE, and applicable local regulations .
- Participate in regulatory inspection preparation and provide engineering support during inspections.
- Ensure appropriate engineering documentation, traceability, change control, and deviation management.

9. Project Controls & Governance

- Develop and maintain the engineering master schedule and critical-path activities.
- Track engineering progress, procurement milestones, construction progress, and commissioning readiness.
- Manage engineering CAPEX and identify cost-saving/value-engineering opportunities.
- Establish project KPIs and provide regular reporting to senior management.
- Proactively identify and mitigate technical and execution risks.

Education: B.E/ B. Tech (Mechanical/ Electrical/ Electronics/ Instrumentation)