Key Responsibilities:
1. Process Design & Optimization
- Provide technical leadership in the design, installation and maintenance of sterilization systems including:
- Steam-In-Place (SIP)
- Clean-In-Place (CIP)
- Autoclaves (Moist Heat Sterilization)
- Dry Heat Ovens/Depyrogenation Tunnels
- Lead the development of process designs, including PFDs, P&IDs, mass and energy balances for sterilization and lyophilization equipment.
- Ensure process functionality, safety, and efficiency in the design of systems such as steam sterilizer, Depyrogenation tunnel and Lyophilizer.
- Support Manufacturing team to define and optimize freeze-drying parameters: freezing, primary drying, and secondary drying.
- 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 equipment.
- 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 sterilization/lyophilization equipment 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 equipment 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 equipment 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.
Deliver training sessions for operations, QA, and maintenance personnel on sterilization/Lyo equipment and procedures.
-
Skills:
- Knowledge of sterilization and lyophilization - Expert
- knowledge of sterilization and Lyo equipment (e.g., IMA, SP Scientific, GEA, Telstar, Fedegari, Getinge) - Expert
- Knowledge of cGMP, FDA, EU Annex 1, ISO 11134/11135/17665, and PDA technical reports - Expert
- Knowledge of thermal validation, load pattern design, cycle optimization, and equipment qualification - Expert.
- Problem-solving, documentation, and cross-functional communication skills - Expert
- Bachelor’s or Master’s degree in Mechanical or Process Engineering.
- 12–15 years of experience in process engineering with specialization in sterilization and lyophilization.
- Deep knowledge of sterilization and Lyo equipment (e.g., IMA, SP Scientific, GEA, Telstar, Fedegari, Getinge).
- Familiarity with cGMP, FDA, EU Annex 1, ISO 11134/11135/17665, and PDA technical reports.
- Experience in thermal validation, load pattern design, cycle optimization, and equipment qualification.
- Strong problem-solving, documentation, and cross-functional communication skills.
Internal candidates who want to apply for that role must have completed atleast minimum 2 years within the current role.
