Thomas Goodwin
Quality Engineer in Biotech
- Role
- Senior Quality Engineer at Biogen
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Thomas Goodwin
As a validation engineer, I have been actively involved in the commissioning, qualification, and validation for new facility buildouts, requalification with active manufacturing areas, and specialized pharmaceutical grade equipment. I have supported validation efforts through project management, document drafting, qualification execution, technical support, aligning SOPs across sites, and as equipment SME. I have worked with many different types of equipment and systems, with experience ranging from COTS equipments, to warehouse temperature mapping, to autoclaves and other sterility equipment.Through these experiences, I have gained the following professional competencies:• Ability to define key requirements and develop test scripts for commissioning and qualification• Draft validation documents for commissioning and qualification of new equipment, as well as for requalification efforts• Execute and organize Validation protocols for pharmaceutical equipment for new facility startup as well as business as usual• Act as SME for Kaye AVS and Valprobe systems
Experience
Senior Quality Engineer
Dec 2022 — Present · Durham, NC, US
Education
University of North Carolina Wilmington
Bachelor's Degree, Physics
2011 — 2015
J. T. Hoggard High School
General studies, General Studies
2007 — 2011
Skills
- Chemistry
- Gantt Project
- Microsoft Office
- Powerpoint
- Microsoft Excel
- Thermodynamics
- Testing
- Autocad
- Physics
- Microsoft Word
- Project Management
- Engineering
- Mechanical Engineering
- Optics
- Water
- Troubleshooting
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