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Validation Engineer

Company: Katalyst HealthCares & Life Sciences
Location: Irving
Posted on: May 28, 2023

Job Description:

Job Description


  • Reviews pre-defined deliverables/activities as identified in the Validation Process and/or Product Quality Process/project plan or equivalent project plan.
  • pplies basic risk management principles to all activities and tasks to investigate non-conformances.
  • Identifies areas for process improvement and provides supporting information for change, including reasons and justifications.
  • Participates in the development or modification of validation packages and deliverables, including, assessments (including risk assessments, e.g., FMEAs), plans, requirements, and protocols.
  • Works independently with objectives given by the FUE Validation Manager.
  • Can plan and coordinate own work according to higher level project schedules.
  • Review documentation for accuracy, clarity, consistency, completeness and compliance for multiple projects.
  • Including System Specifications/Requirements documents, Validation protocols, Trace Matrices and Validation Summary Reports for the client's Transfusion Medicine (TM) Dallas site.
  • Report unexpected events, issues or software bugs which occur during validation to project team and management. Requirements:
    • ssist team members in meeting their goals by providing coaching and mentoring as needed.
    • Maintain schedule and drive to meet validation schedule as aligned with project(s) goals.
    • Ensure that appropriate procedures, controls, and disaster recovery plans are incorporated into new FUE systems.
    • Bachelor's degree in life sciences, engineering, or a closely related discipline OR relevant combination of education and/or experience.
    • Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11/Annex 11.
    • Project experience in validation testing practices, methodologies and techniques, particularly in testing medical devices or experience leading test engineer team is a plus.
    • Must have excellent oral and written communication skills.

Keywords: Katalyst HealthCares & Life Sciences, Irving , Validation Engineer, Engineering , Irving, Texas

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