Role Overview
Seeking an experienced Validation Analyst to support Roche's GIP program, focusing on validation of medical imaging applications, AI/ML workflows, and the Algorithm Workbench platform. The role will ensure system quality, regulatory compliance, data integrity, and end-to-end validation readiness.
Key Responsibilities
· Develop and execute Computer System Validation (CSV) deliverables, including validation plans, risk assessments, IQ/OQ/PQ protocols, and validation summary reports.
· Validate medical imaging workflows, algorithm development processes, data pipelines, and integration with downstream applications.
· Collaborate with data scientists, algorithm engineers, business analysts, QA, and development teams to define validation requirements and acceptance criteria.
· Create and maintain requirements traceability matrices (RTM), test scripts, execution evidence, and defect documentation.
· Support functional, integration, regression, and User Acceptance Testing (UAT), ensuring end-to-end traceability.
· Assess validation impact of system enhancements, algorithm updates, and configuration changes.
· Ensure alignment with applicable GxP, GAMP 5, FDA 21 CFR Part 11, and internal quality standards.
· Support audit readiness, deviation management, CAPA activities, and release validation sign-off.
Required Qualifications
· 5+ years of experience in software validation, CSV, or quality assurance within life sciences, pharmaceutical, or medical technology environments.
· Experience validating cloud-based applications, medical imaging platforms, or regulated software systems.
· Strong understanding of SDLC, Agile methodologies, risk-based validation, and software testing.
· Experience with Jira, Confluence, test management tools, and validation documentation.
· Excellent communication skills and ability to collaborate with cross-functional technical and business teams.
Preferred: Experience with AI/ML model validation, medical imaging algorithms, AWS-based platforms, and data science workbenches.
