Must possess the following at least 5 years of experience in validating COTS, configured COTS and XaaS systems; at least 5 years of experience with business process modeling and requirements management tools JIRA, Visio, ALM, and TopTeam; at least 5 years of experience with traditional waterfall model and iterativeagile development methodologies; at least 5 years of experience implementing and maintaining riskbased validation model strategies; at least 5 years of experience with computer system validation, Software development lifecycle concepts and their implementation in an IT organization; at least 5 years of Project Management experience; and at least 4 years of experience in an FDA GXP regulated industry i.e. such as pharmaceutical, medical device, or biotechnology.

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