Shrikrishna V Dongre

Lead Process Engineer for upcoming cGMP Insulin plant in Malaysia. from July - Till now

• Handling several important process equipment packages at different stage for ongoing project
• Optimized several process equipment to minimize manual intervention during operation while keeping capital investment at check
• Established and Implemented templates for defining scope, technical evaluation and design document reviews to streamline processes

Lead Process Engineer, Injectable Facility. from April 2022 - June 2022

• Driven Project to success at crucial juncture, though involved at later stage
• Resolved complex challenges surfaced during of installation of qualification in timely manner. Bridged gap in expectation and understanding between Equipment Suppliers and user team while keeping regulatory requirement in mind.
• During this period handled Filling machine with isolator and Lyophilizer among other major Process Equipment

Lead Process Engineer for upcoming cGMP Insulin plant in Malaysia. from 2021 - March, 2022

• Optimized over 50 process equipment and utility P&IDs for better automation with lower cost impact
• Procured critical process equipment such as Autoclaves, Harvest Tanks, Crystallizer tanks, GMP Washers etc.

Lead Process Engineer for Hybrid cGMP microbial plant from 2018-2021.

• Developed various FEED, Concept Design and Detailed Design documents along with user team and design consultant
• Designed, procured and Qualified process equipment such as TFF, Autoclaves, Homogenizer etc.
• Developed handshakes between DCS and Various smart equipment
• Played crucial role in implementing continuous kill System for the first time in Syngene
• Responsible for closure of various qualification documents DQ, FAT, SAT and IQ/OQ. Been driving force and facilitated closure deviations with minimal cost and time impact. Managed logistics at site during pandemic

Lead Process Engineer for cGMP Microbial Plant 2016-2018

• Developed various FEED, Concept Design and Detailed Design documents along with user team and design consultant documents.
• Developed Equipment layout and Personnel-material movement philosophy.
• Responsible for designing, procuring and Qualifying process equipments such as Autoclave, Single Use Systems, Chromatography systems, and supporting equipment such as TCUs, Neutralization System etc.
• Participated in Facility risk assessment and framing mitigation strategy.
• Responsible for closure of various qualification documents DQ, FAT, SAT and IQ/OQ. Managed to close deviations with minimal cost and time impact.
• Contributed to developing project schedules and monitored tasks to meet milestones during each phase. Managed logistics at site .

Lead Engineer for Brownfield Hybrid cGMP Microbial Facility Project

• Conducted feasibility study for technology transfer
• Assessed gap, developed Equipment List and Layout
• Developed Process schedules, mapped utility and redesigned utility distribution system to meet new process requirement
• Prepared Process Budget & Schedule and monitored to meet milestones during each phase
• Evaluated vendors and procured major process equipment including, TFF System, Homogenizer, Chromatography Systems and Single Use systems
• Responsible for closure of various qualification stage documents DQ and FAT. Managed to close deviations with minimal cost and time impact

• Learnt basics of various Bio-pharmaceutical USP and DSP operations, facility & equipment design, regulatory affairs and good documentation practices.