Manager, Process Engineering (SME - Isolator & Filling Lines)

Key Responsibilities:

1. Process Design Optimization

• Lead the design, development, troubleshooting and optimization of aseptic filling processes for vials, PFS, bags, and cartridges.
• Review and provide support to validate process parameters (e.g., filling speed, accuracy, container closure integrity) ensuring product quality and sterility assurance.
• Collaborate with equipment vendors and cross-functional teams for Installation, Commissioning and Troubleshooting to ensure process suitability and compliance.

2. Operational Excellence, Maintece 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 maintece 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, maintece costs, and the percentage of planned maintece are met as per requirement.
• Provide expert support for troubleshooting operational issues in aseptic filling and container handling.
• 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.
• Responsible for the preparation, review, and finalization of detailed process engineering designs and specifications for Process systems (e.g., Cartridge filling line with isolator, PFS filling machine with Isolator, Vial filling machine with Isolator/CRABs/ORABs) 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, PIDs, and all associated process-related execution drawings.
• Ensure proper integration of isolators, RABS, filling machines, and supporting automation (SCADA, BMS, EMS).
• Review PIDs, 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 (PIDs), 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 filling line is 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 filling operations.

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:

• Knowledge of Isolator filling lines (Vial, PFS, Bag, Cartridge). - Expert
• Familiarity with equipment from major OEMs (e.g., Bausch + Str bel, IMA, Optima, Syntegon, Groninger) - Expert
• Knowledge of cGMP, FDA, EU Annex 1, ISO 11134/11135/17665, and PDA technical reports - Expert
• knowledge of filling technologies (rotary piston, peristaltic pump, time-pressure), container closure systems, and sterilization methods (SIP, CIP). - Expert.
• Problem-solving, documentation, and cross-functional communication skills - Expert