Hemit Goswami

Background

About Hemit Goswami

Masters in Mechanical Engineering with experience and proficiency in validation to support equipment as well as process reviews by writing documentation and test scripts followed by their execution to successfully validate and sustain a cGMP compliant production operation, on an ongoing basis. Excellent communication skills with strong analytical & problem-solving aptitude, coupled with demonstrated ability to complete tasks efficiently in a time sensitive environment • Experienced in supporting Validation activities for Bio-Pharma operations from writing documentation such as protocols, test scripts, deviations, draft SOPs, support calibration, alarm and interlock testing, risk assessment to field execution, cycle development studies, thermal mapping, troubleshooting, deviation resolutions, evaluating and compiling test data, preparing reports and obtaining its approvals. • Preparation and development of P & ID and PFD (AutoCAD), process design calculation, energy and mass balance, line sizing and pressure drop calculations. • Responsible for Handling of Deviations, Standard Operating Procedure (SOP) and Batch Manufacturing Record (BMR). • Skilled in troubleshooting, validating manufacturing processes and following procedures. • Project experience in process modelling, simulation, and optimization. • The excellent cross-functional understanding between Manufacturing, Validation, Quality, Engineering, Maintenance, and Compliance. • Completed specific internal training in: o Instruments Hands-on: Kaye Validator, Sartorius Biostat STR Bioreactor, Shimadzu UV-2700 UV-Vis Spectrophotometer, Beckman Coulter Vi-Cell Metaflex o Other Systems: Master Control (EDMS), ProCal (CMMS). o Special Training: Clean-in-Place (CIP), Steam-in-place (SIP) systems’ design, qualification, validation and operation including cycle development studies, troubleshooting, instrumentation and PLC based controls. o Regulatory requirements: 21 CFR - Part 211, Part 11, Part 820, ISO 14644 and USP 32. o Software Skills: AutoCAD, Solidworks, MS Excel (Macros), MS Office, MATLAB/Simulink