Validation Analyst (f/m/d)
Core
Ensure test devices for Precision Motion, Respiratory, and Cardiac business lines work as intended for pharma customers by executing validation tests and maintaining compliance documentation.
Role type
Validation Analyst
Builds
Validation documentation and test reports for clinical data systems and test devices
Domain
Life Sciences / Medical Devices / Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP knowledge, 21CFR Part 11 compliance, test strategy development, deviation tracking, system configuration evaluation, Microsoft Office proficiency
Preferred skills
Knowledge of electronic record requirements, experience with third-party vendor systems
Technologies
Microsoft Word, Microsoft Excel, PowerPoint
Responsibilities
Write validation documentation (Test Strategies, Test Reports, Deviations), evaluate systems for validation steps, document and track test deviations, interact with development staff on specifications, support QA audits, review test reports, execute test reports, perform quality reviews, coordinate end-user training
Seniority
Junior to Mid-level, hands-on IC
