Job Description

Role Summary: We are seeking an Expert– Projects Design with robust expertise in formulation projects facility design, engineering, and oversee project execution. The role will be responsible for leading the planning, design, engineering, execution, commissioning, qualification, and operational handover of manufacturing facilities while ensuring compliance with global regulatory requirements and industry best practices.

The ideal candidate will have extensive experience in Oral Solids, Oral Liquids, Topicals, Sterile Injectables, Aseptic Processing & Fill-Finish Facilities along with a proven track record of successfully delivering Greenfield, Brownfield, expansion, and modernization projects.

Key Responsibilities

1. Project Planning & Governance

- Lead Conceptual, Basic and Detailed Engineering activities for formulation projects.
- Develop facility master plans, site development strategies, project roadmaps, and long-term manufacturing infrastructure plans.
- Prepare CAPEX estimates, project budgets, business cases, investment proposals, and project schedules &Manage; project scope, cost, timelines, resources, and quality objectives.
- Deliver projects within approved budgets and timelines while maintaining compliance and quality standards.

2. Facility Design & Engineering

- Design GMP-compliant manufacturing facilities for OSDs, Oral Liquids, Topicals, Sterile Injectable Manufacturing, Aseptic Processing Facilities & Fill-Finish Facilities
- Develop facility concepts, process flow diagrams, block layouts, and detailed facility layouts.
- Optimize material, personnel, equipment,



and waste flows to improve operational efficiency and regulatory compliance.
- Review URS, process requirements, engineering deliverables, and design documentation.
- Ensure designs comply with FDA, EU GMP, WHO GMP, ISPE & local regulatory requirements.

3. Greenfield, Brownfield & Capacity Expansion Projects

- Lead end-to-end project design & execution from concept development.
- Manage site selection inputs, facility planning, construction, commissioning, qualification.
- Execute modernization projects while minimizing impact on commercial operations.

4. Utilities, HVAC & Cleanroom Systems

- Design & review of HVAC, Clean Utility Systems including Purified Water (PW), Water for Injection (WFI), Pure Steam (PS), Clean Compressed Air, Process Gases
- Design review of Black Utility Systems including HVAC Utilities, Boilers, Chillers, Cooling Towers, Air Compressors, Fire Protection Systems, Drain & Industrial Water Systems
- Ensure compliance with ASME BPE, ISPE guidelines & pharmaceutical engineering standards.

- Develop facilities up to ISO 5 / Grade A & ensure environments ensuring pressure cascade philosophies, contamination control strategies, and airflow concepts.

5. Equipment Engineering Co-ordination & Qualification & Compliance

- Equipment selection & evaluations, procurement,



installation & qualification activities.
- Review equipment layouts, utility requirements, and process integration requirements.
- Support and oversee DQ, IQ, OQ & PQ activities.

- Ensure facilities comply with FDA, EU, WHO, MHRA & applicable regulatory expectations.

6. Vendor, Contractor & Stake holder Management

- Evaluate and select EPC contractors, consultants, and equipment suppliers.
- Review vendor proposals, technical offers, and engineering deliverables.
- Monitor contractor performance, quality compliance, project schedules, and commitments.
- Participate in technical negotiations, and vendor development initiatives.
- Collaborate effectively with Production, QA, Validation, Automation, Engineering, SCM, Procurement, Finance, Regulatory Affairs, and SHE teams.

7. Operational Excellence, Automation & Sustainability

- Drive value engineering initiatives to optimize CAPEX and OPEX without compromising quality and compliance.
- Identify opportunities to improve facility efficiency, productivity, reliability & energy performance.
- Support automation, digitalization, and Industry 4.0 initiatives across manufacturing and utility systems.
- Provide engineering oversight for serialization, packaging automation, AMRs, ASRS, and smart manufacturing solutions.
- Promote Safety-by-Design principles and ensure compliance with EHS requirements.
- Participate in risk assessments, HAZOP studies, and sustainability initiatives including energy conservation, water management, and green building practices.
- Drive value engineering initiatives to optimize CAPEX and OPEX.

📌 Expert Project Design (Hyderabad)
🏢 Dr. Reddy's Laboratories
📍 Hyderabad