Kijun Do Email & Phone Number

South Korea

Technical Advisor in ISPE Korea Affiliate

분당

- Bioprocess and API Engineering- Bioprocess Equipment Design and Engineering- Validation Consulting and Execution- cGMP Planning and Consulting- Open Collaboration with the Partners which have own strength points- Strategic Planning- New Business Development- Project Management and Control

Korea

1. Biopharm facility and process design2. Specific Operation, CIP and SIP concept3. Piping study, 3D modeling and Engineering Document Package for validation4. Cleaning and Passivation 5. Functional Design Specification6. Equipment and Process Validation7. Facility cGMP readiness8. Operation occupancy for optimized operation schedule and de-bottlenecking9. SOP guide and generation support10. Re-validation with scientific… Show more 1. Biopharm facility and process design2. Specific Operation, CIP and SIP concept3. Piping study, 3D modeling and Engineering Document Package for validation4. Cleaning and Passivation 5. Functional Design Specification6. Equipment and Process Validation7. Facility cGMP readiness8. Operation occupancy for optimized operation schedule and de-bottlenecking9. SOP guide and generation support10. Re-validation with scientific rationale to minimize validation points11. Project Management with Critical Path for Fast Track Approach12. Data Sheet Generation, Review13. Facility Design Review for Operation, Maintenance and Cross Contamination.14. Project and Risk Management15. PID Tuning and Operation Optimization16. Trouble Shooting and Resolution Planning Show less

송도

Plant III Upstream Engineering and Validation Management Lead1. Upstream process and engineering design review - P&ID - Occupancy List - GA drawingns - Data sheet - FDS - Terms of Reference - 3D Modeling 2. Validation concept and approach - Equipment Impact Assessment - User Requirement Specification - Quality Risk Assessment - Design Review - System Verification Plan3… Show more Plant III Upstream Engineering and Validation Management Lead1. Upstream process and engineering design review - P&ID - Occupancy List - GA drawingns - Data sheet - FDS - Terms of Reference - 3D Modeling 2. Validation concept and approach - Equipment Impact Assessment - User Requirement Specification - Quality Risk Assessment - Design Review - System Verification Plan3. Project equipmemt design review and technical support - Bioreactors (up to 15k) - Disk stack centrifuge - Depth and sterile filter skid - Autoclave (including liquid cycle) - Parts washer - Process vessels - CIP skids - Temperature control skid - High temperature short time skids - Raw material handling - Tempered Water Skid4. Process equipment verification - Process vessel FAT - Sprayball coverage test - Drainability test5. Training for new employee6. Internal suggestion and improvement review and evaluation7. New and experienced people general job and technical interview Show less

대한민국 인천 송도

1. DS Manufacturing Plant I Upstream Detail Design - Bioreactor Project (5000L x 6ea), FDS Generation, P&ID Development - Plant on a page and Overall Upstream Process Design - Process Equipment FAT Lead - Site Management for Construction and Equipment Installation2. DS Manufacturing Plant I Validation Support and Trouble Shooting - CIP Cleaning and SIP Cycle Development3. DS Manufacturing Plant II Upstream Detail Design - Bioreactor… Show more 1. DS Manufacturing Plant I Upstream Detail Design - Bioreactor Project (5000L x 6ea), FDS Generation, P&ID Development - Plant on a page and Overall Upstream Process Design - Process Equipment FAT Lead - Site Management for Construction and Equipment Installation2. DS Manufacturing Plant I Validation Support and Trouble Shooting - CIP Cleaning and SIP Cycle Development3. DS Manufacturing Plant II Upstream Detail Design - Bioreactor Project (15K x 10ea), FDS Generation, P&ID Development - Plant on a page and Overall Upstream Process Design - Process Equipment FAT Lead - Site Management for Construction and Equipment Installation4. DS Manufacturing Plant II Validation Support and Trouble Shooting - Validation Protocol Development and Training for Operators - Overall Validation Planning and Manpower Management for Upstream Part - Detail Daily Base Planning and Execution Lead 5. Technology Transfer Support for CMO Clients - Upstream Process Plant Tour Lead and Presentation - Process Gap Analysis - Process Modification to meet Customer Processes6. Manufacturing cGMP Preparation - SOP - Training - Material Flow and Storage - Labels7. Process Fit Review and Large Scale Test - Level verification for Density Difference - High Temperature Short Time - Critical Step Simulation - Mixing Study - Material Handling and Optimization - Full Sterilization Mapping8. Product Engineering Runs - Planning and Production Lead - Batch Record Review - Cleaning Verification - Product Specific Mixing Study - Manufacturing Scheduling (Detail Daily Base) - Trouble Shooting9. Product Clinical Runs10. DS Manufacturing Plant III Upstream Process Design Review - User Requirement Specification - Quality Risk Assessment (FMEA) - P&ID, GA Drawing and FDS - Data Sheet and GA Drawing - 3D Modeling Show less

Korea

1. Manufacturing Operation - Bioreactor Production Lead and Schedule Management - Unit Operation Management - Trouble Shooting and Inspection - CIP, P-test, SIP, Media Filling, Conditioning, Inoculation, Culture, Feed Supervisor - Shake and Spinner Flask Culture2. Training - Training for Manufacturing Operation - Hands on Training for Bioreactor Operation and Maintenance

Korea

1. Document Setup and Development for New Facility - SOP for Manufacturing Process - Manufacturing Batch Record(MBR) for Production - Equipment Log and Status - Registration and Submission Form2. Manufacturing Operation - Raw Material Handling Procedure and Method. - Media Preparatio and Filtration (Small scale for Inoculum and Large Scale up to 12,500L) - Media Preparation and Hold Schedule Management - Mobile Vessel and Large Scale Vessel… Show more 1. Document Setup and Development for New Facility - SOP for Manufacturing Process - Manufacturing Batch Record(MBR) for Production - Equipment Log and Status - Registration and Submission Form2. Manufacturing Operation - Raw Material Handling Procedure and Method. - Media Preparatio and Filtration (Small scale for Inoculum and Large Scale up to 12,500L) - Media Preparation and Hold Schedule Management - Mobile Vessel and Large Scale Vessel Operation - Technology Transfer for CMO Product - Process Time and Motion Study3. Validation for Process Equipments for New Facility - URS, RA, DQ, FAT, SAT, IQ, OQ and PQ VSR Docuement Development - Execution and Deviation Control - Report Generation - US FDA Inspection Preparation and Interview Show less

Master, Biopharmaceutical

Bachelor, Life Science And Computer Engineering