ITCSVEngineer

**Job Title:** IT CSV Engineer **Location:** Seattle, WA OR Redmond, WA **Reports to** : Senior Manager/Group Leader, CSV **About Us:** At Just-Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged, it’s celebrated. Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you! **The Role:** We’re looking for a passionate and curious IT CSV Engineer to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. As an IT CSV Engineer at Just-Evotec, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team. **What You 'll Do:** * Lead validation efforts for Manufacturing (MFG), Quality Control (QC), enterprise, and PP&D systems within the Sandoz remediation initiative. * Ensure adherence to client requirements, regulatory compliance, and project timelines. * Collaborate with cross-functional teams to execute complex Computer System Validation (CSV) projects, including remediation and new system implementations. * Develop validation strategies and author validation documents such as validation master plans, data migration plans, protocols, reports, and discrepancy resolutions. * Manage and optimize validation testing processes, ensuring risk-based validation approaches align with current FDA Computer Software Assurance (CSA) principles and GAMP5 practices. * Standa