Nithin M.
Sr.Process Development & Validation Consultant
- Role
- Validation Consultant at Regeneron
- Location
- San Diego, US
- LinkedIn followers
- 500 followers
About Nithin M.
Currently Open for New Opportunities). • Validation and Process development Expert with over 6 years of experience in Medical Device industry with diverse engineering experience including manufacturing/production, design/development, and qualification. • Expert in reviewing equipment design, with a proven track record of foreseeing potential issues and implementing solutions to mitigate bottlenecks to meet client requirements. • Extensive experience in Process Validation, Complaint Handling, Risk Management, Process Development, Process Controls, Continuous Quality Improvement and Lean Six Sigma projects in the medical industry • Strong knowledge of the FDA Regulations, 21 CFR part 210, 211, 820 part 11, ISO 14971:2019, ISO 13485:2016. Expertise in risk-based sampling and data analysis. • Experienced in equipment trouble shooting, statistical analysis, yield improvement, Change Management. • Qualified several clean rooms (ISO 8, ISO 5) and worked with lab equipment (Autoclaves, refrigerators, Incubators, Temperature and Humidity monitors, Kaye Validator) I have a solid educational foundation and a passion for Validation and Quality. For additional details about my expertise and career achievements please go through my Linkedin. You can contact me on: mail id: n••••••••@gmail.com phone:+19•••••••90
Experience
Validation Consultant
Jun 2023 — Present · NY, US
Education
Binghamton University
Master's degree, Systems Science and Industrial Engineering
2017
BIT Mesra Student-Industry Relations Cell
Bachelors Degree, Mechanical Engineering
2012 — 2016
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