Laboratory Systems Validation Specialist 1
Core
Leading system validations, test efforts, and requirement gathering for laboratory instruments, middleware, LIS/LIMS, and automation platforms to ensure regulatory compliance and data workflow integrity.
Role type
Laboratory Systems Validation Specialist
Builds
Validated laboratory systems, middleware interfaces, and automated data workflows for clinical testing environments
Domain
Life Sciences / Clinical Laboratory Information Systems (LIS/LIMS)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Laboratory instrument operation, LIS/LIMS integration, Lab Middleware (Data Innovations, Siemens), GxP compliance, CAP/CLIA environment experience, SDLC/GAMP methodologies, test plan development, requirement documentation, stakeholder communication, issue escalation, performance monitoring
Preferred skills
GAMP experience, SDLC experience
Technologies
Data Innovations Instrument Manager, Siemens ADM, LIS, LIMS
Responsibilities
Lead system validations for instruments and middleware, develop and execute test efforts for laboratory workflows, gather requirements for middleware interface development, produce validation documentation, monitor system testing execution and resolve issues, coordinate resources with IT and project managers, ensure regulatory compliance and quality standards
Seniority
Individual Contributor, Project Lead
