Sethuraman Senthilnathan
About Sethuraman Senthilnathan
Sethuraman Senthilnathan is an MES IT Analyst at Bristol Myers Squibb in Bothell, Washington, with a background in chemical engineering and extensive experience in validation and compliance.
Current Role at Bristol Myers Squibb
Sethuraman Senthilnathan is currently employed as an MES IT Analyst at Bristol Myers Squibb, located in Bothell, Washington, United States. In this role, Sethuraman leads the MES team, focusing on compliance, handling Deviations, CAPAs, and driving Change Controls. He manages MES processes and operations for manufacturing both clinical and commercial finished drug products. His proficiency in 21 CFR Part 11 compliance ensures adherence to FDA regulations.
Past Experience at bluebird bio
In 2018, Sethuraman Senthilnathan worked at bluebird bio as a Validation Engineer. During his five-month tenure in Cambridge, Massachusetts, United States, he was responsible for ensuring that systems and processes met specified validation requirements. His work contributed to maintaining standards required in the biopharmaceutical industry.
Validation Analyst at Science 37
From 2017 to 2018, Sethuraman Senthilnathan held the position of Validation Analyst at Science 37 in Los Angeles, California, United States. Over seven months, he specialized in ensuring that systems and software used in clinical trials complied with regulatory standards. His role was critical in maintaining data integrity and ensuring reliable trial results.
Graduate Research Assistant at Arizona State University
Between 2014 and 2017, Sethuraman Senthilnathan served as a Graduate Research Assistant at Arizona State University in Tempe, Arizona, United States. During his three-year tenure, he worked on various research projects within the Ira A. Fulton Schools of Engineering. His research contributed to advancements in chemical engineering, particularly in material characterization.
Educational Background
Sethuraman Senthilnathan holds a Master's Degree in Chemical Engineering from the Ira A. Fulton Schools of Engineering at Arizona State University. He also earned a Bachelor's Degree in Chemical Engineering from Amrita Vishwa Vidyapeetham, Coimbatore. His educational background provided a strong foundation for his expertise in material characterization, data integrity, and compliance with regulatory standards.
Professional Certifications
Sethuraman Senthilnathan is certified as a Six Sigma Green Belt by the American Society for Quality (ASQ). This certification underscores his competence in process improvement and quality management. It complements his specialization in computer systems, instrument, and equipment validation.
Specialization in FDA Compliance
Sethuraman Senthilnathan specializes in 21 CFR Part 11 compliance, ensuring that electronic records and signatures meet FDA regulations. His experience ensures that manufacturing processes are reliable and adhere to rigorous standards, crucial for the pharmaceutical and biotech industries.