PRAVEEN K.S.N

Presently Working for Amneal Biosciences Pvt Ltd as Process Engineer for Greenfield project. Hands on Experience from the Vial Thaw stage to Harvest, including SIP, CIP of Fermentor, Media Preparations, sterile filtrations, Aseptic Handlings. Experienced in Brownfield and Greenfield projects Projects Handled in Commercial Scale: ( MAMMALIAN AND MICROBIAL ) Equipment's Handled: Shaker Incubator - shake flask Single use wave bioreactor biostat B 10L Single use bioreactor wave 25/50L GE singel use bioreactor 200L GE & Thermo singel use bioreactor 1000L GE & Thermo SS bioreactors 70L, 1200L - sartorius SS bioreactors 1800L biozeen SS bioreactors 400L bioengineering. TFF Chromatography. Docking station 200L to 1000L Biowelders and Bio sealers software integrated with SS bioreactors: windows siemens software handled on single use bioreactors: wonder ware and Finesse Tru Bio Delta V. Software of ISIS for CO2 shaker incubator. MFCS for biostat B Cultibag wave bioreactor Primary Product Capture: West Falia Separator ( Make: GEA, Alfa Laval), Disruption System : Homogenizer GEA, Dynomil (Make: Willyabachofen) HPHV Autoclave Standard (Make: Machinfabrik) Analytical Equipments Handled: Visual Spectrometer, Microscope, Precision Balance, Eppendorf Centrifuge, Biosafety Cabinet, Laminar Air Flow Unit. Validation: Cleaning Validation, Process Validation, Media Simulations. QA Related: Coordinating with QA for investigations, Responsible for closure of incidents, Deviations and CAPA Responsible for getting compliance for the checks of line clearance and start up check list. Documentation: SOPs, BPRs, Protocols, SAP. QMS: Deviations, CAPA, Change Control. Root cause analysis. Qualifications: Vendor assessment, URS, SLIA, QP, VP, SB, CLIA, DQR, RA, RTM IQ, OQ, PQ, QSR, VSR. Member of Area Excellence Team towards SQDECC and LEAN practice Lead for the following in Manufacturing COMMISSIONING & QUALIFICATIONS of process equipments. EXECUTION of process manufacturing QMS related to process manufacturing RERUITMENTS to process manufacturing