Validation Engineer (CSV/CSA, GAMP)

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

The Opportunity:

As an IT Professional Validation Lead, you will play a crucial role in ensuring the quality of our products. Your responsibilities will include evaluating, designing, developing, and approving validation plans, protocols, and reports for computerized systems across various domains and product lines. In collaboration with the Quality Assurance and product teams, you will ensure that products are manufactured, implemented, and maintained in compliance with regulatory agency validation requirements, company standards, and current industry practices.

You will work closely with the product and Software Quality Assurance (SQA/Testing) teams to define test strategies and coverage, as well as review and approve test results. Additionally, you will continuously assess and review internal validation processes and procedures, making recommendations for improvements.You will be part of a highly motivated, collaborative, and diverse Computer Software Assurance/Validation Team.

You will be:

• Determine validation approaches, and identify deliverables needed or impacted by a project/enhancement / change for GxP computerized systems
• Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance
• Develop validation plans/reports, reviews test plans/reports (and other deliverables), and assess, authorize, and notify that the system is ready to go live
• Verify testing plans, activities, deliverables, and records, provide consultancy on test-related deviations and corrective actions according to approved procedures
• Support in deviation investigations to identify root causes and define corrective and/or preventative actions. Support system audit/inspection preparation and execution as CSV subject matter expert. Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection readySupport system periodic reviews according to company procedure

Who You Are:

• Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field
• Over 3 years in IT & Software Validation (CSV/CSA, GAMP)
• Familiarity with FDA regulations/guidance (CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices)
• Understanding of system and data risk assessment, and general knowledge of Agile Methodology (SAFe, Scrum)
• Strong communication skills, ability to work in cross-functional and agile teams, and assertiveness in diverse environments

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.