Donggun Michael Ko Email & Phone Number

Madison, WI, US

Melrose Park, Illinois, United States

• Manage product launch on new automated manufacturing lines by developing manufacturing processes in formulation, filling, and cleaning
• Manage cross-functional teams to optimize manufacturing through master batch record optimization, scale-up, and product validation
• Optimize production by process qualification for new primary packaging components and alternative raw materials
• Improve capability of currently defined manufacturing Critical Quality Attribute for pharmaceuticals by performing routine continuous process verification
• Lead OOX investigation and design CAPA for product deviation through SOP update, Change Control, and Root Cause Analysis
• Utilize risk analysis technique to develop robust manufacturing processes for the transfer of products.

Melrose Park, Illinois, United States

• Served as qualifications Study Director and generated protocols of Design Qualification (DQ), Installation and Operation Qualification (IOQ), and Performance Qualification (PQ) for Vial Washer and Depyrogenation Tunnel.
• Served as the Subject Matter Experts (SME) on automated filling line for Vial Washer and Depyrogenation Tunnel including production Recipe optimization, and troubleshooting/solving.
• Developed User Required Specification, Site Acceptance test, Risk Assessment, Design Review Table, Data Integrity Risk Assessment, Meta Data Risk Assessment, and Final Reports for Vial Washer and Depyrogenation Tunnel.
• Executed and lead temperature mapping studies for Isolator and Depyrogenation Tunnel using Kaye Validation System.
• Managed Deviations and Change Controls for commissioning and qualification.
• Generated Standard Operating Procedures (SOP) for Isolator, Vial Washer, and Depyrogenation Tunnel.

Chicago, Illinois, United States

- Validation Engineer for Vial Washer and Depyrogenation Tunnel at Fresenius Kabi USA for Expansion Project, Automated Filling Line for Cytotoxic and Hormon

Madison, Wisconsin, United States

• Developing solvent-targeted recovery and precipitation of waste plastics to improve recycling process for multilayer plastics
• Following SOPs and safety protocols to learn the current process and maintain safe lab environment
• Utilizing batch process, FTIR, pH meter, burner flask filtration, thermocouple, Excel, and Minitab to obtain and analyze results
• Achieving 10% of plastic recovery and 60% ink removal through iteratively improving upon the result within 3 months
• Collaborating and communicating with Ph.D. students and a professor to give and get feedbacks about progress and results
• Presenting methods processes, and results during university poster session to professors, faculty, and students

Pittsburgh, Pennsylvania, United States

• Authored 3 SOPs in collaboration with a manufacturing manager to increase the reproducibility of paints
• Improved paint thickness measurement up to 30% by training technicians to use a new optical device within the QC process
• Spearheaded a client complaint by communicating with manufacturers and managers about analyzed data of 4 colors
• Conducted audit over 300 paint panels at a customer plant to decrease 40% of customer’s color complaints
• Utilized optical devices, Excel, and Minitab to manipulate and analyze data to report to managers about customer complaints
• Examined and adjusted 120 internal color specifications by using manufacturing data to prevent future customer complains

Gwangyang, Jeollanam-do, Korea

• Assisted in designing 2 ventilation system models by lowering 8% fine dust emission using ANSYS
• Led two internal meetings about ventilation system optimization and participated in meetings with the client
• Designed and created front cover page and technological section in advertising website

Pyeongtaek, Gyeonggi-do, Korea, USAG Humphreys

-United States Army Intelligence and Security Command, 501st Military Intelligence Brigade-Served as a Ground Force Division (GFD) Analyst and Cryptologic Linguist.-Ran real time mission in team of 10 and taught mission over 30 soldiers.-Developed time sensitive daily products to Korean Theater Analysis and Control Element (ACE), U.S. Forces Korea (USFK).

Pohang, Gyeongsangbuk-do, Korea

• Assisted Ph.D. students with lab experiments and data analysis
• Created superhydrophobic and superhydrophilic plates with nanomaterials using properties from lotus leaves
• Analyzed superhydrophobic/philic characteristics using high speed cameras by calculating the angle from droplet size
• Grew nano-size pillars with various nanomaterials and different types of boards using spraying methods

Houston, Texas Area

• Collected and organized data to share amongst team in order to improve the efficiency of vessel production
• Assisted project for Chevron in a modeling of Floating Production Storage and Offloading (FPSO) vessel
• Led the meeting with the product seller for building FPSO vessel

Bachelor Of Science - Bs, Chemical Engineering, 3.574/4.0

Activities and Societies: Engineering EXPO (2016-2017)-Team Leader American Institute of Chemical Engineering (AIChE) UW-Madison.

High School Diploma, 3.89/4.0