Roche is advancing science and building a new portfolio of products in Cell and Gene Therapy (CGT), driving life-changing treatments for patients. We are business minded technology experts in CGT acting as a pioneer in this new era in medicine. We are currently searching for a Computer System Validation Lead to oversee the compliance and validation of our digital solutions. In this position, your primary focus will be ensuring that all software, systems, and processes function exactly as intended and strictly align with regulatory requirements and quality standards. By actively collaborating with product managers, RTEs, software developers, system owners, and key business stakeholders, you will empower teams to successfully manufacture and deliver high-quality pharmaceutical products.
Formulate and deploy validation strategies for digital solutions, aligning with corporate benchmarks, industry best practices, and regulatory mandates. Produce exhaustive validation protocols and plans for CGT applications, automated tools, and data-driven interfaces,



ensuring comprehensive documentation of all activities.
Ensure strict adherence to data integrity regulations and GMP standards, maintaining highly accurate logs, plans, and change controls.
Qualification & Core Testing: Work alongside multidisciplinary teams and QA Subject Matter Experts (SMEs) to perform qualification benchmarks, execute test scenarios, analyze performance data, and report findings.
Assume the role of System Owner for assigned software applications throughout the CGT digital landscape.
Bachelor's degree in computer science, information systems or a related study (or equivalent project-related experience)
~5+ years of relevant experience as a Validation /CSV Expert providing mission-critical services in a general organization, preferably within the highly regulated Life Sciences industry
~ Practical experience with cloud platforms (AWS, Google Cloud) and ServiceNow, alongside familiarity with test automat

📌 Computer System Validation Lead for Cell (España)
🏢 Roche Holding
📍 España