Abhishek Shrivastava

WORK HISTORY

EDUCATION

ABOUT ABHISHEK SHRIVASTAVA

I am a master\'s in Industrial Biotechnology currently working as Associate Manager - Projects & Process Engineering at Biocon Biologics, a fully integrated global Biosimilars Organisation. I have more than 9 years of experience in process engineering. Skilled in process design and qualification activities according to cGMP requirements and execution and managing of Greenfield and Brownfield projects from BD to DD.The roles & responsibility include: • Process design including Preparation of process description, Process module diagram, Process flow diagram, Operation flow diagram, P & IDs, Capacity calculation, Utility consumption calculation, Hydraulic Calculations, Equipment sizing calculations, Vent & Overflow line sizing, FS preparation, CIP/SIP philosophy, Waste philosophy, Equipment Layout and specification and area classification. • Preparation of technical data sheets of the systems, Interdisciplinary design coordination with internal engineering department (Process, HVAC, Piping & 3D Modelling, Instrumentation, Electrical, Procurement), Clean room coordination with the piping team (including inputs to 3D Modelling of the systems) for the packages, Active part in 3D Model area reviews at different detailed design phases (30%, 60% 90%) of packages. • Support client (as required) for FAT, Vendor design documentation reviews and approval, Design support for any issues related to On-site construction related to packages and commissioning & qualification activities.• Also previously worked for the upstream manufacturing of microbial as well as mammalian biosimilars upto scale, disposable bioreactor upto scale, harvest, UF/DF, homogenization and transfer of broth to downstream facility, QMS documentation like preparation & review of MFR, BMR & SOP, handling of change control & deviations with appropriate CAPA and preparation and execution of VMP/RTM/URS/DQ/FS/FAT/SAT/IQ/OQ/PQ/PV/CV/QRM of all process equipments.