Sasi Kumar Kollapudi

About Sasi Kumar Kollapudi

I\'m a Senior Validation and Quality Engineer with over 6 years of progressive experience in the pharmaceutical and medical device industries, specializing in process validation, computer system validation (CSV), cleaning validation, and quality systems. I bring deep expertise in regulatory compliance (FDA 21 CFR Parts 11, 210, 211, 820, ISO 13485, ISO 14971, EU MDR), validation lifecycle management, and risk-based quality engineering. Throughout my career, I have led the validation of critical systems including ERP, MES, SCADA, PLCs, and eQMS platforms (Veeva Vault, TrackWise), ensuring data integrity under ALCOA+ principles. My work spans equipment qualification, sterilization validation, cleaning verification, and supplier quality audits, all contributing to successful FDA, EU, and internal audits with zero major findings. With a strong foundation in analytical tools like Minitab and methodologies such as FMEA, DMAIC, PDCA, and 5S, I help drive process improvements and reduce recurring deviations. I am also passionate about leveraging Six Sigma and quality engineering principles to enhance product quality and operational efficiency.

Experience

1. Senior Validation Engineer

   Vein360

   Oct 2023 — Present · Blue Ash, OH, US

Education

• University of Cincinnati

  Master of Science - MS

  2023 — 2024

• R.V.R. & J.C. College of Engineering

  Bachelor of Technology - BTech

  2015 — 2019