Job Description

Key Responsibilities:

1. Process Design & Optimization

Lead the development of process designs, including PFDs, P&IDs, mass and energy balances for skids, tanks, and filtration vessels. Ensure process functionality, safety, and efficiency in the design of systems such as manufacturing and filtration skids, chemical dosing systems, and CIP/SIP systems. Specify process equipment, instrumentation, and control strategies in alignment with client requirements and international standards (ASME, API, IEC, etc.).

2. Operational Excellence, Maintenance & Troubleshooting

Responsible for supervision and monitoring of day-to-day site activities from a process engineering perspective, ensuring stringent adherence to quality, cGMP regulations, and safety norms related to process operations. Proactively engage in troubleshooting and resolution of on-site process-related challenges and deviations. Responsible for Troubleshooting of issues, periodic health check-up of Process Equipment and effective preventive maintenance across various Amneal plant. To take necessary steps for reduction of equipment breakdown and ensure that certain KPIs such as Mean Time Between Failure (MTBF), Mean Time to Repair (MTR), unscheduled downtime, maintenance costs, and the percentage of planned maintenance are met as per requirement. Provide expert support for troubleshooting operational issues in process vessels. Ensure that periodic calibration activity of instruments are done as per SOP. Responsible for the delivery of high-quality work output from all engaged vendors and consultants pertaining to process systems, meeting project specifications and timelines. Proactively identify and implement areas for improvement during equipment selection and installation activities to optimize system performance, efficiency, and overall process reliability.

3. Equipment Selection & Configuration

Review User Requirement Specifications (URS) and participate in vendor evaluations and design reviews. Evaluate and optimize skid and vessel designs to ensure optimal flow distribution, separation efficiency, and pressure drop. Troubleshoot process issues during manufacturing and testing phases, and provide technically sound solutions. Responsible for the preparation, review, and finalization of detailed process engineering designs and specifications for Process Vessels (e.g.,Manufacturing and Filtration vessels, CIP/SIP System and associated instruments) with a focus on process flow and system optimization. Responsible for the preparation, review, and finalization of Bills of Quantity (BOQ) and Tender documents for Process Equipment's/Systems, ensuring accurate process equipment and material specifications. Responsible for the preparation, review, evaluation, and technical assessment of vendors for Process Equipment's/systems, with a strong emphasis on process suitability, efficiency, and reliability. This includes the preparation and finalization of comprehensive technical comparison sheets to support informed process equipment and system selection. Responsible for the preparation, review, and timely finalization of PFDs, P&IDs, and all associated process-related execution drawings. Ensure proper integration of Process Vessels with filling machines or other associated upstream/downstream machines and supporting automation (SCADA, BMS, EMS). Review P&IDs, layout drawings, and functional design specifications (FDS) for compliance with aseptic design principles.

4. Compliance, Validation & Documentation

Responsible for the preparation, review, and finalization of critical process technical documents, including process concept notes, process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and User Requirement Specifications (URS) for Process Equipment's/systems, in close coordination with external consultants and cross-functional departments. Responsible for the qualification and validation of Process Vessels are in line with regulatory requirements, focusing on process performance and quality attributes. Drive and support investigations (e.g., deviations, CAPA, root cause analysis) related to operation.

5. Cross-Functional Collaboration & Training

Serve as the technical liaison between quality, validation, manufacturing, and external vendors. Train operations and engineering staff on equipment functionality, SOPs, and Good engineering practices.
Skills:


process design, maintenance and projects of modular skid packages, pressure vessels and associated systems. - Expert understanding of process simulation tools (e.g., Aspen HYSYS, ChemCAD) and CAD software for P&ID development/review - Expert knowledge of fluid dynamics, heat and mass transfer, and separation technologies - Expert communication, leadership, and problem-solving skills - Expert

Bachelor's or Master's degree in Mechanical or Process Engineering. 12-15 years of experience in process design, maintenance and projects of modular skid packages, pressure vessels and associated systems. Strong understanding of process simulation tools (e.g., Aspen HYSYS, ChemCAD) and CAD software for P&ID development/review. In-depth knowledge of fluid dynamics, heat and mass transfer, and separation technologies. * Effective communication, leadership, and problem-solving skills.