Kevin Lee

About Kevin Lee

With hands-on experience in supporting GMP-regulated environments, I bring a strong combination of commissioning, qualification, and computer system validation expertise aligned with FDA and global regulatory expectations.|| Worked on supporting risk-based validation activities for equipment, utilities, and computerized systems, ensuring compliance with FDA 21 CFR Parts 210, 211, and 11, as well as EU GMP and GAMP 5 principles. I have authored, executed, and reviewed IQ, OQ, and PQ protocols, validation plans, risk assessments, and summary reports while maintaining strong traceability to URS and business requirements.|| My experience spans managing change controls, performing system impact and risk assessments, reviewing test scripts and execution evidence, and supporting deviation investigations and CAPAs. I have collaborated closely with Engineering, Automation, Manufacturing, QA, and IT teams to ensure validation activities are efficiently executed without compromising compliance or data integrity.|| I am motivated by opportunities that allow me to contribute to compliant system implementation, process optimization, and continuous improvement within regulated manufacturing environments. I would welcome the opportunity to bring my CQV and CSV expertise, attention to detail.|

Experience

1. Validation Engineer

   Abbott

   Apr 2022 — Present · Plymouth, MN, US

Education

• China Pharmaceutical University

  Bachelor of Pharmacy - BPharm, 2014

• University of California, Berkeley

  Master of Technology - MTech, 2017