Lakshmi C.
About Lakshmi C.
Lakshmi C. is a CSV Engineer at Bristol Myers Squibb with extensive experience in validation and compliance within the pharmaceutical, biotechnology, and medical device industries.
Current Role at Bristol Myers Squibb
Lakshmi C. is currently employed as a CSV Engineer at Bristol Myers Squibb in Summit, New Jersey, United States. In this role, she applies her expertise in maintaining compliance with FDA standards within the Pharmaceutical, Biotechnology, and Medical Device industries. Her responsibilities likely include developing and executing validation protocols such as IQ, OQ, PQ, as well as conducting data integrity assessments to ensure compliance and accuracy.
Previous Positions in the Pharmaceuticals Industry
Before her current role, Lakshmi C. has amassed significant experience through various positions in the pharmaceuticals industry. She worked as a CSV Specialist at Lupin Pharmaceuticals in Somerset, New Jersey, for 7 months in 2020. Prior to that, she served as a QA Validation Consultant at Regeneron Pharmaceuticals, Inc. in Rensselaer, New York, for 5 months from 2019 to 2020. She also held the role of Validation Engineer at Pfizer in McPherson, Kansas, from 2018 to 2019 for one year. Additionally, she has worked at Edwards Lifesciences in Irvine, California, as a Validation Engineer for 7 months in 2017, and at Yale New Haven Hospital as a Student Intern for 2 months in 2016.
Educational Background
Lakshmi C. holds a Master of Science degree in Healthcare Informatics from Sacred Heart University, equipping her with a robust foundation in the intersection of healthcare and information technology. She also has a Bachelor's degree in Pharmacy from Osmania University, providing her with essential knowledge and skills in pharmaceutical sciences.
Specialized Expertise and Skills
Lakshmi C. possesses comprehensive expertise in FDA predicates, including 21 CFR Part 11, 210, 211, 820, GMP, GLP, GDP, and GAMP. She specializes in maintaining compliance with FDA standards in the Pharmaceutical, Biotechnology, and Medical Device industries. Her skill set includes developing and executing validation protocols such as IQ, OQ, PQ, conducting data integrity assessments, and performing root cause analysis to identify and resolve issues. Additionally, she is skilled in commissioning and qualification of manufacturing equipment, facility, and utility systems, and is proficient in SAT, FAT, and vendor protocols.