At Roche you can show up as yourself, embraced for the unique qualities you bring. At Roche, compliance is our license to operate, and we are committed to delivering high-quality products. As a Senior IT Validation Professional, you will play a pivotal role in ensuring the quality of the products we deliver. Description of the area The specific computerized systems related to this role are general purpose platforms for automation and application development. Determine validation approaches and identify deliverables needed or impacted by projects, enhancements, or changes for GxP computerized systems.
review and authorize test plans and reports, ensuring the system is ready to go live.
Testing and Consultancy: Verify testing plans, activities, deliverables, and records. Provide consultancy on test-related deviations and corrective actions as per approved procedures.
Deviation and Root Cause Analysis: Support investigations into deviations, identifying root causes, and defining corrective and preventive actions.
System Maintenance: Training and Knowledge Sharing:



Provide training and exchange validation/quality knowledge and experience.
Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.
Experience: Minimum 6+ years of experience in IT & Software Validation (CSV/CSA, GAMP) in pharma environment including: Leading validation / qualification for projects and system maintenance. Reviewing validation and testing-related deliverables, records, and other evidence, including relevant system documentation. Maintaining and supporting applications under integral audit and inspection agencies.
e Veeva) and with ALM Tools (like ServiceNow, JIRA, or similar)
Risk Assessment: Strong expertise in system and data risk assessment.
Agile Methodology: Good understanding of Agile Methodology (Frameworks such as SAFe, Scrum); Ability to work collaboratively in multiple cross-functional and agile teams to achieve milestones and goals.
proficiency in English

📌 Validation Lead (España)
🏢 F. Hoffmann-La Roche
📍 España