? Support smooth execution of new products during T&V.
? Coordinate with R&D, QA, QC, Production, and EHS for knowledge transfer.
? Participate in lab trials to understand CPPs/CQAs. Conduct lab experiments to generate scale-up data.
? Prepare Process Data Sheets and generate mass/energy balances for lab and plant scales.
? Engineering calculations based on lab study for smooth scale up.
? Assist in scale-up strategy, equipment mapping, and support validation batches.
? Develop/review P&IDs and PFDs.
? Support batch monitoring & troubleshooting and investigate process deviations.
? Prepare Technical Investigation Reports with CAPA.
? Conduct HAZOP and HIRA for new and modified processes.
? Support change control documentation.
? GMP and EHS compliance as part of the departmental culture.
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