Validation Analyst

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 .