Rajat Desai
Director of Operations @Kashiv BioSciences LLC
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WORK HISTORY
Director of Operations @Kashiv BioSciences LLC
Bridgewater, NJ, US
Responsible for R&D Manufacturing Operation, Equipment Procurement, and Process Development Support.Responsible for Validation of equipment, utilities, HVAC, environment and continuous monitoring system for solid dosage pharmaceutical facility.Responsible for generating change control, URS for projects, SOP for equipment and systems.Responsible for providing update and project timelines to management for qualification projects.Contributor to Health and Safety audit for Clinical Research Organization (CRO) business.Coordinating soft containment procurement and surrogate testing for potent compound usage in facility.
EDUCATION
New Jersey Institute of Technology
Master of Science, Electrical Engineering
New Jersey Institute of Technology
Master's degree, Electrical, Electronics and Communications Engineering
SKILLS
ABOUT RAJAT DESAI
Skills• 10 years of extensive experience in the Biotech, Solid Dosage & Medical Devices industry• Manufacturing Operations, Process Development & Equipment Procurement Process equipment qualification and Process Utilities (Clean steam, WFI, Purified Water and Compressed air) qualification• Siemens and Honeywell Building Management System and HVAC qualification• Computerized systems qualification for 21CFR11 Compliance• Cleaning validation of Bioreactors and Processing equipment• Change control, Engineering assessment & Standard Operational Procedures development to support production activities• Experienced in generating the summary reports for Regulatory Approval• Hands on experience with Validation equipment such as GE Kaye Validator ValProbe, Mesa labs Data Tracers, MET-ONE Model A2408, Surface Air Sampler Super 100™, Steam Quality Test Kit SQ1, Vaisala temperature and humidity indicator, Fluke Multimeter, Edge Tech Dew Point Moisture Analyzer etc.• Software Skills: AUTOCAD, MS - Project, MS - Excel, MS - Word, MS - PowerPoint, MS - Visio and MATLAB, Geomagic• PLC Programming Tools: RSLogix, Siemens STEP 7, TI Soft, Wonderware InTouch, RSView, Siemens APOGEE Insight and InfoCenter
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