Lead Design Engineer I

India

Basic understanding for GLP, GMP, and other pharma regulatory standards.

Must have Expertise on Technology transfer & scaleup from Lab scale to commercial scale.
Preparation BEP documents for Technology Transfer like Design Basis , BFD, PFD, Mass balance , energy balance, line sizing calculation , Instrument data sheet preparation & Suitable MOC Selection.
Involves Process optimization, scaleup and scale down of unit operations (Mixing, Reaction, Extraction, Distillation, Crystallization, Filtration & Drying, etc.)
Optimize process parameters to improve efficiency, yield, and cost-effectiveness.
Involves in Effluent treatment philosophy , Solvent recovery, and Recycling Methodologies.
Optimizing process with minimum effluents and maximum productivity.
Design and develop pharmaceutical manufacturing processes (batch and continuous) for new dedicated or Multipurpose plant.
Conduct process simulations and modelling using tools like Aspen HYSYS.
Process Intensification using next generation techniques of flow chemistry and working on reaction kinetics
Close collaboration with process safety team to study process for thermal safety (DSC, ARC, RC1E) etc.
Close collaboration with R&D scientist for optimizing and conceptualizing process flow at plant scale.
Anticipating problems of commercial scale and resolve during process development stage
Close collaboration with Engg. Lab team for process scale-up, scale down and engineering optimization, engineering data generation (VLE data, crystallization PSD, filtration rate, drying curve, extraction studies etc.)
Close collaboration with pilot/KL team for piloting/Kilo lab activities, BEP preparation, P&ID preparation, participating in hazop, and successful piloting/KL activity.
Close collaboration with MPP and Dedicated design team for transfer of finalized process (tech transfer package)
Working on established plants and processes for troubleshooting and eliminating process challenges
Stay updated with industry advancements and integrate new technologies.
Preparation of Tech Transfer Report (TTR) for commercial batch execution at plant.
Ensure compliance with cGMP, and other regulatory standards.