Role OverviewThe Manufacturing, Scientist 1 will be responsible for representing Operations in design teams, facilitating design transfer, and leading sustaining engineering projects for improvement of manufacturing processes. They will also identify opportunities for process innovations, develop product stability plans, and ensure effective training of Manufacturing and Quality Control personnel.
What You Will Do
The Manufacturing, Scientist 1 will be responsible for representing Operations in design teams, facilitating design transfer, and leading sustaining engineering projects for improvement of manufacturing processes. They will also identify opportunities for process innovations, develop product stability plans, and ensure effective training of Manufacturing and Quality Control personnel.
Why It Might Be a Fit
The ideal candidate will have a Bachelor's Degree in Chemistry/Chemical Engineering, Microbiology, Life Sciences, or Biomechanical Engineering, and 5+ years of reagent Operations experience in a relevant ISO 13485 and/or FDA regulated setting. They will also have knowledge of ISO 13485 and FDA Quality System requirements, Enterprise Resource Planning, and Process and Test Method Validations.
Requirements
- Bachelor's Degree in Chemistry/Chemical Engineering, Microbiology, Life Sciences, or Biomechanical Engineering
- 5+ years of reagent Operations experience in a relevant ISO 13485 and/or FDA regulated setting
- Knowledge of ISO 13485 and FDA Quality System requirements
- Knowledge of Enterprise Resource Planning
- Knowledge of Process and Test Method Validations
Benefits
- Competitive salary and benefits package
- Opportunity to grow career and impact the lives of people worldwide
- Diverse perspectives and innovation
- Equal opportunity employer
- Reasonable accommodations for qualified individuals with disabilities
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