Sin Hooi Hng

1. Involve in the Greenfield Project as Pioneer team for Critical Manufacturing MES system roll out 2. Involve in MES knowledge transfer from sister site located in China 3. Act as a Subject Matter Expert for some critical MES functions and gather the user requirements or new request for enhancement for the related topics 4. Support full test and validations for major system upgrades, sprints and release of new functions 5. Support the maintenance of MES system for the configuration, setup and Master Data upload 6. Support User Acceptance Test of the system before system Go Live 7. Provide training for MES key users and Ops Team in respect of system functionalities and features 8. Support MES training documentations, IT KB and MES User Guide video creation for MES functions 9. Communicate with supplier on issue found during validations as well as new requests of the function 10. Working cross-functionally with other departments and provide guidance on setting up the data and requirements in the system 11. Align and liaise with MES teams from different locations on the requirements with current solutions 12. Pick up and execute the Service Now tickets within the agreed SLA timeframe 13. As a level 2 support for production issues found related to MES SME topics 14. Support key users enquiries and issues in respect of system functionality and features 15. Communicate and liaise with key users on the new requests/requirements on the MES functionalities 16. Communicate with SAP team in terms of SAP-MES integration issue 17. Define test scenarios for related SME topics in a structured and standards-based approach

Experiences : 1. Support the roll out of Critical Manufacturing MES system across production lines in the shopfloor 2. Support full test and MES system validations for major upgrades, sprint release and release of new functionalities 3. Liase with businessusers and support/resolve MES issues to ensure availability and performance 4. Communicate with business users and gather information on the new function/requirement and draft for the URS 5. Create training documents and provide hands on training to key users with sometests to ensure the effectiveness of training 6. Liase with business users on the Master Data setup and preparationin each production line in the shopfloor 7. Support Software Development Team on report development by gathering the requirements and information for MES reporting from business users 8. Support MES reporting validations 9. Support the configuration, setup and maintenance of MES system 10. Communicateand work with MES Vendors on the new functionality requirements and issues encountered 11. Collaborate with other departments especially SAP in solving MES-SAP integration issues 12. Explore and create interactive dashboard using Microsoft Power BI

Experiences in Medical Industry : 1. Carry out NC (Non conformance) disposition to decide whether to rework, scrap or accept the unit through MES system. 2. Carry out investigations to identify the root cause of certain product defects using 6 step problem solving. 3. Carry out Tool Qualification (TQ) on some tools and equipment used in the cleanroom. 4. Carry out Fast Track and Full Track Change Notice through Windchill. 5. Weekly yield reporting and analysis through Excel. 6. Dealing with vendor on the stitching aids purchasement. 7. Assisting in setting up new line in the production, dealing mainly with qualification tasks. 8. Qualify or validate equipment in the line.

During my internship period, I have involved in some projects like Statistical Engineering Analysis Tool (SEAT) Phase 2 projects which helped to manage the universal tensile tester - Zwick data in order for them to be written into the SAP database as well as generating the control limit chart by using the Minitab Statistical tool for SPC in order to obtain the limit value to control the process. Besides, I also helped with the protocol standardization, user management, as well as expanded traceability set up in the Zwick machines. Expanded Traceability is a FDA CFR Part 21 requirement that must be fulfilled for documentations. I prepared process workflow in customer complaint monitoring as well as for PM activity workflow. I generated quite a lot of Teaching Guides for the users as a reference to assist them in performing tasks. Basically, I am involved in the improvement projects which helped to enhance the product quality.

This course is about the study of : -process control , lean manufacturing six sigma: reduce the wastes & improve the entire process -facilities management: how the building structure and environment affects the health and performance of employees -Good Practices (GxP) like Good Manufacturing Practices and Good Engineering Practices & Good Documentation Document -Quality Control, Quality Assurance & Regulatory Affairs: importance of quality to be built into the process to produce high quality products -equipment qualification & system validation: an equipment must be qualified for a system to be validated -Environmental, Health and Safety (EHS) on how the manufacturing process, product, environment and employees are interrelated -industrial statistics: process capabilities like Cpk values, upper & lower control limit which is crucial for a quality process -ISO standards like ISO9001 & ISO13485 (Medical Devices): standard that must be complied in order to market the products