Wonmin Kim Safety & industrial engineering GC Biopharma

Wonmin Kim Safety & industrial engineering

Wonmin Kim Safety & industrial engineering GC Biopharma Packaging 2 Part Leader

Won Min Kim Part Leader, Packaging[OCP] Packaging 2Part, GC Biopharma Won Min Kim currently serves as the Leader of the Packaging 2 Part, Packaging[OCP] Team at GC Biopharma, overseeing Automated Visual Inspection (AVI) and Manual Visual Inspection (MVI) processes, as well as vial packaging operations for parenteral drug products. He is responsible for the establishment and maintenance of all AVI and MVI validation data, including initial qualification, routine revalidation, and change-control validation. His responsibilities also cover two vial packaging lines — one multi-packaging and one single-packaging line — ensuring compliant and efficient commercial operations. Mr. Kim successfully led the installation, setup, and full validation of a new Koerber vial automated inspection system and the qualification of manual inspection procedures, ensuring inspection performance consistency and regulatory compliance with USP <1790>, EU Annex 1, and related guidelines. Before joining GC Biopharma in 2022, he worked at Celltrion Pharm as an AVI engineer, responsible for syringe auto inspection system validation as well as utility equipment qualification including part washers, autoclaves, and laminar flow hoods. With over eight years of experience in visual inspection validation, defect data management, and regulatory audit preparation, Mr. Kim is deeply specialized in the establishment and lifecycle management of visual inspection systems for sterile injectable products.