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Responsibilities:

• Hands-on CSV specialist on assigned projects, responsible for the creation, execution, and coordination of the project's CSV deliverables.
• CSV advisory for the planned projects
• Training of testers and approvers of CSV processes and systems
• Perform Protocol Exception Assessments and Resolutions
• Provide support to testers, as needed, with validation questions.
• At all times, exemplify the highest level of business and personal integrity.
• Must be able to work nights & weekends.
• Bachelor of Science in an Engineering, Computer Systems or Science Field

Requirements:

• 3-5 years' experience as a CSV specialist within the Life Sciences Industry
• 1-2 years' experience with ERP validation, SAP S/4 HANA experience preferred.
• Knowledgeable in US and Global Computer system Validation requirements
• Knowledge of GAMP 5 methodology
• Experience with Val Genesis, preferred.
• Detail-oriented with ability to accomplish objectives.
• Demonstrated ability to work independently.