Company: Katalyst HealthCares & Life Sciences
Posted on: May 28, 2023
- 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
- 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
- Can plan and coordinate own work according to higher level
- 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
- 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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