Yen

About Yen

Engineering professional with demonstrated ability to implement controlled change and innovative improvements to deliver results. Diversified professional background with experience in quality, analytical, chemical engineering, project management, operations, and supervisory functions in GMP pharmaceutical manufacturing. Skilled with direct experience in: technical operations, validation, life cycle management, lean manufacturing, GMP compliance, statistical data analysis, chemical processing, risk and financial assessments, analytical testing, continued process verification, lean six-sigma black belt training, business impact evaluations, change management, and leading cross-functional project teams.

Experience

1. Manufacturing Process Specialist Lead

   Noramco

   Aug 2015 — Present · Wilmington, DE, US

Education

• Drexel University

  Bachelor's Degree, Biomedical Engineering

  2000 — 2005

• UC San Diego

  Professional Certificate in Quality Assurance and Control for the Drug and Biologic Industry

  2009 — 2010

• Drexel University

  Master's Degree, Biomedical Engineering

  2005 — 2007

Skills

• Fda
• Gmp
• Quality System
• Analytical Techniques
• Project Planning
• Supply Chain
• Capa
• Technology Integration
• Root Cause Analysis
• Strategic Planning
• Microsoft Office
• Master Data Management
• Lean Six Sigma
• Data Analysis
• Equipment Qualification
• Minitab
• Product Introduction
• Lean Manufacturing
• Technical Leadership
• Project Management
• Employee Training
• Continuous Improvement
• Value Stream Mapping
• Validation
• Cleaning Validation
• Process Improvement
• Process Capability
• Technical Writing
• Teamwork
• Risk Management
• Cross-Functional Team Leadership
• Statistics
• Engineering
• Process Engineering
• Sap
• Technical Support
• Team Building
• Product Specification
• Change Management
• Process Safety