Business Systems and Validation Analyst III
Core
Validating lab instrumentation in accordance with EMA guidelines and managing system development lifecycle deliverables.
Role type
Business Systems and Validation Analyst
Builds
Validated lab instrumentation systems for clinical research
Domain
Life Sciences / Clinical Research / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
System risk assessment, System validation test case creation, Testing summary report generation, System diagram creation, EMA regulatory guideline knowledge, SDLC understanding, Clinical trials operational processes knowledge, SOP/WPD application, Project effort estimation, Problem-solving, Analytical skills, Planning, Organizational skills
Preferred skills
MS Office proficiency
Technologies
MS Office
Responsibilities
Perform system risk assessments, Create system validation test cases and testing summary reports, Create system diagrams, Work on project timelines, Participate in client and regulatory inspections, Collaborate with departments and vendors
Seniority
Mid-level, hands-on IC
