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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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