Manager, Process Engineering

• Overall Responsible for leading process engineering activities for project work, ensuring optimal process design, efficiency, and integration across all initiatives.
• Responsible for comprehensive project planning and scheduling for all process engineering initiatives, ensuring timely execution and achievement of critical milestones from a process standpoint.
• 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, Component processing system, Automatic Visual Inspection Machine for Cartridge, Automatic Visual Inspection Machine for PFS, Manufacturing Vessels, Filtration Vessels, Steam sterilizer, Parts Washer, Pen Device assembly Machine, Auto-injector assembly Machine, Autocartonator, Labelling Machine, Blister Packing, Checkweigher, Mixing system for single use bag, Cold room, BOPP Taping machine, Track and Trace system, Garment Washing and Drying machines, Peptide Synthesizer, VTD, Cleavage Reactor, Liquid Phase Reactor, Centrifuge, ANFD, DAC System, TFF System, LYO, Solvent/Day Tanks & Skids), with a focus on process flow and system optimization.
• 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 preparation, review, and finalization of Bills of Quantity (BOQ) and Tender documents for all 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 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 the preparation, review, and timely finalization of PFDs, P&IDs, and all associated process-related execution drawings.
• Responsible for the delivery of high-quality work output from all engaged vendors and consultants pertaining to process systems, meeting project specifications and timelines.
• Conduct thorough review and finalization of joint measurement records for process equipment and materials and be responsible for the accurate verification and approval of vendor bills.
• Coordinate effectively with government authorities for all necessary liaison work and the acquisition of required project approvals related to process system installations and operations.
• Responsible for the installation and commissioning of process equipment's/systems, including but not limited to BFS Line, BAGS Line, Terminal Sterilization, PFS Line, Vial Line in Aseptic Filling ensuring process parameters are met.
• Responsible for the qualification and validation of process systems (DP and DS Equipment's/Systems) in line with regulatory requirements, focusing on process performance and quality attributes.
• Proactively identify and implement areas for improvement during process equipment selection and installation activities to optimize system performance, efficiency, and overall process reliability.
• Foster and maintain strong coordination with Cross-Functional Teams (CFTs) for seamless day-to-day process operations, data exchange, and project integration.

Education:
Bachelor's or Master's degree in Chemical Engineering, Process Engineering, or related discipline.

Experience:
10–15 years of experience in process engineering within pharmaceutical or biotech manufacturing, including aseptic filling and complex process systems.

Technical Expertise:

• Strong knowledge of process design, PFDs, P&IDs, and URS preparation.
• Hands-on experience with process equipment (e.g., isolators, filling lines, sterilizers, reactors, filtration systems).
• Familiarity with cGMP, regulatory compliance, and validation protocols.

Skills:

• Project planning and execution.
• Vendor evaluation and technical assessment.
• Cross-functional coordination and leadership.