Paul Chen Email & Phone Number

Taiwan

Luzhu District, Taoyuan City, Taiwan

• Lead 20+ validation engineers for equipment qualification and medical device manufacturing process validation with focus on assembly process. • Link product specifications and user requirements to the validation activities and ensure manufacturing process can deliver products that constantly meet specifications.• Supervise process improvement projects, trouble shooting, and deviation investigations.

Luzhu District, Taoyuan City, Taiwan

• Equipment Validation (IOPQ for qualifying fully customized equipment for auto-injectors assembly).• Assembly Process Validation for medical devices (auto-injectors). • Technical project handling of a highly complex auto-injector with fully automatic assembly machine.• Generate GMP validation documents.• Support internal/external audits from the government and from pharma customers.

Xinfeng Township, Taiwan, Taiwan

• Leading raw material/packaging component qualification cross-function team (Quality, Regulatory, Procurement, Finance, Production, Engineering, Technical Services).• Work with procurement and suppliers to investigate and improve material quality issues or to customize material attributes to better fit site production process needs.• Site contact for global technical forum, communicating with colleagues around the world (U.S.A., Canada, Brazil, Italy, Taiwan, Mainland China… Show more • Leading raw material/packaging component qualification cross-function team (Quality, Regulatory, Procurement, Finance, Production, Engineering, Technical Services).• Work with procurement and suppliers to investigate and improve material quality issues or to customize material attributes to better fit site production process needs.• Site contact for global technical forum, communicating with colleagues around the world (U.S.A., Canada, Brazil, Italy, Taiwan, Mainland China, etc.).• Managing product transfer projects (R&D to manufacturing site, and site to site transfer). • Dealing with manufacturing/packaging process improvement, trouble shooting.• Budgeting and product cost setup.• ERP BOM creation and maintenance- SAP.• Support ERP system transition from SAP to Infor Lx.• Generating GMP documents and supporting audits from Taiwan FDA, from supplied markets (Colombia, South Korea), and from external customers (Costco, RT-MART, etc.). Show less

Xinfeng Township, Taiwan, Taiwan

• Managed raw material qualification (new materials or alternative sources). Managed 100+ materials changes to assure supply continuity, cost saving, and compliance to most updated regulatory requirements. • Generated GMP documents and support audits.• Participated in internal audit program as lead auditor since 2018.• Acquired and implemented six sigma methodology (Certified six sigma yellow belt holder).

Zhunan Township, Taiwan, Taiwan

• Conducted product technology transfer from U.S.A. manufacturing site to Taiwan site. • Generated GMP documents and support US FDA audit.• Conducted process study, process validation, process improvement projects.

Master Of Science - Ms, Industrial Engineering

Bachelor Of Science, Chemistry, Chemistry