Expert Project Design
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Role Summary: We are seeking an Expert– Projects Design with strong 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.
Required Qualifications & Skills
Education: Bachelor’s degree in mechanical engineering (B. Tech / B.E.)
Experience: 6+ years of experience in Greenfield, Brownfield expansions of formulation facility design & execution.
Technical Skills: Pharmaceutical Facility Design, Facility Master Planning, Utilities & Infrastructure Engineering, HVAC & Cleanroom Design, Qualification & Validation, Automation & Digitalization, CAPEX Planning & Cost Control, Risk Management, Engineering Change Management, Contamination Control, Regulatory Compliance, Vendor & Contractor Management
Software Proficiency: AutoCAD, SAP, MS Project, Microsoft Office
Additional Information
Global Manufacturing Organisation (GMO)
At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry.
We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities.
Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future.
Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com
Job details
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