Job Title: Validation Analyst

Project: Medical Imaging & Algorithm Workbench
Location: San Francisco, CA
Work Model: Hybrid – 4 Days Onsite

Role Overview

We are seeking an experienced Validation Analyst to support Roche’s GIP program, focusing on the validation of medical imaging applications, AI/ML workflows, and the Algorithm Workbench platform.

The ideal candidate will ensure system quality, regulatory compliance, data integrity, and end-to-end validation readiness while supporting software releases and system enhancements within a regulated life sciences environment.

Key Responsibilities

• Develop and execute Computer System Validation (CSV) deliverables, including validation plans, risk assessments, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, and validation summary reports.

• Validate medical imaging workflows, algorithm development processes, data pipelines, and integrations with downstream applications.

• Collaborate with data scientists, algorithm engineers, business analysts, QA professionals, and development teams to define validation requirements and acceptance criteria.

• Create and maintain Requirements Traceability Matrices (RTMs), test scripts, test execution evidence, and defect documentation.

• Support functional, integration, regression, and User Acceptance Testing (UAT), ensuring complete end-to-end requirements traceability.

• Assess validation impacts associated with system enhancements, algorithm updates, configuration changes, and software releases.

• Ensure compliance with applicable GxP, GAMP 5, FDA 21 CFR Part 11, and internal quality standards.

• Support audit readiness, deviation management, Corrective and Preventive Action (CAPA) activities, and release validation sign-off.

• Maintain accurate validation documentation and ensure deliverables comply with established quality procedures and regulatory expectations.

Required Qualifications

• 5+ years of experience in software validation, Computer System Validation (CSV), or quality assurance within life sciences, pharmaceutical, biotechnology, or medical technology environments.

• Hands-on experience validating cloud-based applications, medical imaging platforms, or regulated software systems.

• Strong understanding of the Software Development Life Cycle (SDLC), Agile methodologies, risk-based validation, and software testing practices.

• Experience preparing and maintaining validation documentation, including validation plans, risk assessments, test protocols, RTMs, and validation summary reports.

• Familiarity with Jira, Confluence, test management tools, and defect tracking processes.

• Understanding of GxP compliance, GAMP 5 guidelines, FDA 21 CFR Part 11, and data integrity principles.

• Strong analytical, documentation, communication, and problem-solving skills.

• Ability to collaborate effectively with cross-functional technical, quality, and business teams.

Preferred Qualifications

• Experience with AI/ML model validation and algorithm-based applications.

• Familiarity with medical imaging workflows, imaging data, and healthcare technology platforms.

• Experience validating AWS-based applications and cloud-hosted enterprise systems.

• Exposure to data science platforms, Algorithm Workbench environments, and scientific computing workflows.

• Experience working in regulated software development environments with formal change control, audit, and release management processes.

Ideal Candidate Profile

The ideal candidate is a detail-oriented Validation Analyst with strong CSV expertise and experience supporting regulated software systems in the life sciences or medical technology domain.

The candidate should be capable of managing validation deliverables, executing risk-based testing, maintaining requirements traceability, and supporting audit readiness for complex applications involving medical imaging, cloud infrastructure, and AI/ML workflows.