03 Nov
|
Cadila Pharmaceuticals
|
Ankleshwar
03 Nov
Cadila Pharmaceuticals
Ankleshwar
Process Engineering
• Lead process engineering activities for API manufacturing processes, including process understanding, scale-up, and plant optimization.
• Review process flow diagrams (PFDs), P&IDs;, mass and energy balances, equipment specifications, and process calculations.
• Provide engineering support for process development, technology transfer, scale-up, and commercialization.
• Identify opportunities for yield improvement, cycle-time reduction, energy optimization, and capacity enhancement.
• Evaluate process bottlenecks and develop technically feasible improvement solutions.
• Support troubleshooting of process
- and equipment-related issues during manufacturing campaigns.
• Ensure process designs comply with GMP, EHS, and applicable statutory requirements. 2. Project Management
• Lead end-to-end execution of brownfield and greenfield API projects, from concept development to commissioning and handover.
• Prepare project scope, budgets, timelines, resource requirements, and execution strategies.
• Coordinate with Production, Quality, R&D;, EHS, Regulatory, Procurement, Finance, and other stakeholders.
• Manage engineering consultants, EPC contractors, equipment suppliers, and external agencies.
• Monitor project progress against approved schedules, costs, and scope.
• Review and approve engineering deliverables, specifications, layouts, and technical documents.
• Drive timely completion of FAT, installation, commissioning, qualification, and project handover activities. 3. Equipment & Utility Engineering
• Review and finalize technical specifications for reactors, centrifuges, dryers, filters, columns, storage systems, and other API manufacturing equipment.
• Evaluate utility requirements, including HVAC, chilled water, cooling water, steam, compressed air, nitrogen, vacuum, and electrical power.
• Participate in equipment selection, technical evaluation, and vendor finalization.
• Review equipment layouts,
piping arrangements, and material-of-construction requirements.
• Ensure engineering solutions meet operational, safety, reliability, and GMP requirements. 4. GMP, Qualification & Compliance
• Ensure projects are designed and executed in accordance with applicable GMP requirements.
• Coordinate with QA for Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and other qualification activities, as applicable.
• Support preparation and review of User Requirement Specifications (URS), Functional Design Specifications (FDS), engineering design documents, risk assessments, and qualification protocols.
• Ensure appropriate change-control, deviation, and CAPA requirements are addressed during project execution.
• Maintain complete engineering documentation and project records for regulatory audits and inspections. 5. Safety & Risk Management
• Ensure implementation of process safety principles throughout project design and execution.
• Participate in HAZOP, HAZID, What-If studies, risk assessments, and other process safety reviews.
• Ensure appropriate safeguards for hazardous chemicals, high-pressure systems, flammable materials, and critical process operations.
• Coordinate with EHS teams to ensure statutory compliance and adherence to site safety requirements.
• Promote protected engineering practices during installation, commissioning, and plant modification activities. 6. Cost & Vendor Management
• Develop project CAPEX estimates and monitor expenditure against approved budgets.
• Review technical and commercial proposals from suppliers, engineering consultants, and contractors.
• Participate in techno-commercial evaluations and vendor negotiations.
• Identify cost optimization and value engineering opportunities.
• Ensure effective cost control without compromising safety, quality, or technical requirements.
• Develop and maintain relationships with reliable engineering vendors and service providers. 7. Leadership & Team Management
• Lead, mentor, and develop process engineering and project engineering teams.
• Allocate resources and establish priorities across multiple ongoing projects.
• Set departmental objectives, establish performance indicators, and monitor team performance.
• Develop engineering capabilities and build a strong second line of leadership.
• Drive cross-functional collaboration between Engineering, Production, R&D;, QA, QC, and other departments.
• Promote a culture of accountability, technical excellence, innovation, and continuous improvement. 8. Professional Qualifications
• B.
E. / B.
Tech in Chemical Engineering preferred.
• M.
E. / M.
Tech in Chemical Engineering or Process Engineering would be an added advantage.
• Additional qualifications in Project Management or Operations Management are desirable. 9. Experience
• 10–15+ years of experience in process engineering, project engineering, and CAPEX project execution within the pharmaceutical API industry.
• Significant experience in leading large-scale greenfield and brownfield API projects.
• Strong exposure to process design, scale-up, technology transfer, and commercialization.
• Experience in handling multidisciplinary engineering teams and EPC contractors.
• Good understanding of cGMP, regulatory requirements, process safety, and statutory compliance.
• Proven track record of executing complex projects within approved budgets and timelines.
📌 AGM:- Process Engineering (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar