Validation Engineer

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

Job Description:

Job Description

Responsibilities:

• 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