Mani K.
About Mani K.
Mani K. is a Sr. Software Validation Engineer at Teleflex Incorporated in Maple Grove, Minnesota, with extensive experience in quality engineering and validation across various industries.
Current Role at Teleflex Incorporated
Mani K. is currently serving as a Sr. Software Validation Engineer in Quality Engineering at Teleflex Incorporated, located in Maple Grove, Minnesota. In this role, he is responsible for ensuring the accuracy and compliance of software validation processes, focusing on quality engineering principles to deliver reliable software products.
Past Experience at Pfizer
In 2018, Mani K. worked at Pfizer in two different capacities. He served as a Sr. Validation Engineer for EMU for 3 months in Andover, Massachusetts, and as a Sr. Validation Engineer for Remediation for 6 months in McPherson, Kansas. These roles involved ensuring regulatory compliance and the effectiveness of validation processes.
Previous Roles in Validation Engineering
Mani K. has held multiple roles in validation engineering. He worked as a Validation Specialist in Quality Engineering at Renaissance Lakewood, LLC from 2016 to 2018 in Lakewood, New Jersey. Prior to that, he was a Validation Engineer at Avco Consulting, Inc. from 2015 to 2016 in Boston, Massachusetts, and a Computer System Validation Specialist at Sysmex America, Inc. from 2014 to 2015 in Lincolnshire, Illinois. Additionally, he served as a Validation Engineer in Quality Assurance at B Braun Medical (N.I.) Limited from 2012 to 2014 in Irvine, California.
Educational Background
Mani K. has a strong educational foundation in computer science. He obtained a Bachelor's degree in Computer Science from Northwestern Polytechnic University and a Master's degree in Computer Science from Silicon Valley University. Additionally, he achieved a Specialization in Software Development Life Cycle (SDLC); Software Testing and Automation from the University of Minnesota.
Regulatory Compliance Expertise
Mani K. possesses expert-level knowledge in regulatory compliance standards including 21 CFR part 11, 58, 210, 211, 820, 606, and 1271. This expertise ensures that the software and systems he works with meet stringent regulatory requirements, crucial for sectors like pharmaceuticals and medical devices.
Technical Proficiencies and Tools
Throughout his career, Mani K. has gained proficiency with a wide range of application software. Some of the tools he is experienced in include HP ALM, Jira, ePAC, iFIX, DeltaV, SAP, LabWare LIMS, LabVantage LIMS, STARLIMS, Veeva CRM, Veeva Vault, and many more. His technical skills extend to various software development lifecycle models including Waterfall, Agile, and V Model.