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 safe 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.

Qualified

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 (API manufacturing) (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar