Matthew Dang

About Matthew Dang

Education College of Engineering - University of California, Santa Barbara Major:…

Experience

1. Senior Validation Engineer

   Forza Pharma Consulting, Llc

   Oct 2023 — Present · Vacaville, CA, US

   CVS Consultant for Apogee Therapeutics- Implemented Veeva Quality Management System Module on a expedited timeline- Managing Computer Change Controls and project deliverables for configuration changes on Veeva - Developing validation protocols for software configuration changes on Veeva- Performed computer software validation testing for configuration changes on Res_Q- Experience in developing User Requirement Specifications (URSs), Requirement Trace Matrices (RTMs) Validation Plans, User Acceptance Testing (UAT) Protocols, and Validation Summary Reports (VSRs) on Res_Q.Senior Validation Engineer Resource for Polaris PharmaceuticalsSupporting Equipment / Process Systems Validation Remediation- Generation of Site Remediation Qualification Plan - Investigated and assessed GMP equipment systems for validation gaps - Led remediation qualification activities for determined gaps in GMP Equipment systems (ex. Harvest vessels, Centrifuge, Chromatography Skid, HVAC and Clean Room EMPQ, etc.)- Authored and resolved protocol deviations encountered during testing- Generation Qualification and Validation Summary reports to release GMP equipment systems for us. Supporting qualification of GMP lab equipment systems - Investigation and research of lab equipment systems to develop proper lifecycle documentation- Assessing DI gaps for Lab Equipment Systems and developing resolutions for gaps found- Cooperation and communication with Vendors to understand lab equipment systems for qualification- Led qualification on Container Closure Integrity Tester to meed FDA and EMA GMP- Supported qualification of capillary electrophoresis and mass spectrophotometer and their associated software

Education

• UC Santa Barbara

  Bachelor of Science (BS), Chemical Engineering

  2010 — 2015

Skills

• Tennis
• R
• Engineering
• Windows
• Powerpoint
• Microsoft Excel
• Microsoft Office
• Physical Chemistry
• Chemisorption
• Thermodynamics
• Organic Chemistry
• Laboratory
• Ir Spectroscopy
• Music
• Chemistry
• Experimental Design
• Microsoft Powerpoint
• Microsoft Word
• Product Development
• Lotus Notes
• Mathematica
• Process Simulation
• Experimentation
• Design of Experiments