Profile summaryWhat this candidate is looking for
Computer systems validation professional with deep hands-on experience validating laboratory and clinical information systems in FDA-regulated environments
Target rolesClinical Informatics AnalystIT Project ManagerProduct Manager
SkillsComputer systems validation (CSV)FDA 21 CFR Part 11 and Part 820 complianceGAMP 5Risk-based testingValidation plans and protocolsIQ/OQ executionHL7 interface standardsEpic integration testingServiceNowSharePointPowerShellPythonUiPath RPAPower AutomateAnthropic Claude API for AI-assisted toolingSQL ServerAgile and Scrum (Certified ScrumMaster)Project managementRegulatory submission (FDA 510(k))Laboratory and blood bank information systemsDocument controlChange controlDefect triage and resolutionAutomationTechnical mentoring
Remote preferencesLocationPalo Alto, United States
SenioritySenior
Salary target$150k+
Employment typefull-time, contract