Senior Validation Engineer

Job Summary

• Support the Quality Information Systems Management group by collaborating with operational, business, and QA teams.
• Facilitate regulatory assessments, change control reviews, requirements gathering, system design, and system testing.
• Provide quality oversight and assume quality ownership for all computerized system projects.
• Ensure quality compliance and manage quality risks during project implementation and enhancements.
• Participate in cross-functional discussions, offering quality guidance and decisions for system projects (including new implementations, enhancements, releases, and reviews).
• Review and approve quality events (such as deviations and CAPAs), project deliverables, test scripts, and reports.
• Drive system assessments and the resolution of issues related to system quality and compliance.
• Communicate quality risks and mitigation plans to project teams while ensuring ongoing quality assurance throughout all stages of systems development and implementation.
• Leverage expertise in enterprise computerized systems (e.g., ServiceNow, QMS, ERP, Veeva EDC, Compass, RIM, data analytics, lab and manufacturing systems).
• Utilize strong technical writing, communication, and project management skills to deliver innovative and compliant system solutions.

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