Validation Engineer

Company

Karwell Technologies

Location

Durham, North Carolina, United States

Type

Full-time

                Responsibilities:  

   Execute comprehensive verification of digital infrastructure and automated platforms.  

   Generate technical specifications and operational flowcharts alongside hazard evaluations.  

   Draft formal validation strategies as well as testing scripts and final summary data.  

   Uphold strict adherence to FDA regulatory standards for all manufacturing hardware and digital tools.  

   Partner with internal departments to define and record necessary functional parameters.  

   Lead various high-stakes initiatives simultaneously under tight deadlines.  

   Navigate shifting business needs while maintaining high output with little oversight.  

 Requirements:  

   A minimum of five years dedicated to verifying digital systems within the medical technology sector.  

  ...

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Validation Engineer

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