Jaswanth K.
Validation consultant at regeneron
- Role
- Validation Consultant at Regeneron
- Location
- Edison, NJ, US
- LinkedIn followers
- 500 followers
About Jaswanth K.
Engineering Professional within Pharmaceutical/ Biotech industry with expertise in commissioning, qualification, validation, calibration of system/equipment, process improvement & Documentation.• Experienced in generating validation documents such as Validation Plans, SOP’s, WPs, protocols – IQ’s, PQ’s, OQ’s, Test Plan, Status report, Validation Master Plan, Validation Summary Reports.• Experienced as Metrology engineer worked on testing and Troubleshooting equipment & systems and repairing malfunctioning equipment.• Expert in performing measurement, calibration, and validation tasks, ensuring compliance with SOPs, and contributing to the generation of new SOPs.• Knowledge in process control charts, process capability studies, statistical analysis applications.• Experienced in FDA cGxP, 21 CFR Part 11,210, GAMP, ISO, and FDA regulations.• Experience with non-conformance documentation including deviations, investigations, and Corrective Actions, Preventive Actions, and change controls.
Experience
Validation Consultant
Nov 2024 — Present · Rensselaer, NY, US
Education
Anna University Chennai
Bachelor of Engineering - BE, Mechanical Engineering
University of Bridgeport
Master of Science - MS, Technology Management
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