Software Validation Engineer
CurrentFormally ClinPhoneResponsible for supporting the development, delivery and enforcement of fully validated and documented systems and software meeting the regulatory requirements of the FDA. - Assist technical and clinical personnel with the development and delivery of the validation process.- Provide advice and support to all Operations personnel in respect to the validation process.- Author and review call flow charts and ensure that all checks to be performed by the programmer have been included in the programmer test plan.- Author testing documentation for programmer test plans and ensure that all functionality has adequate test scripts and that testing evidence is complete.- Author Project Manager’s test plan and ensure that all scenario testing has adequate test scripts. Review testing evidence for completeness and resolve any issues and inadequacies.- Attend internal project specification reviews and advise on testing for functionality to be used in the project.- Ensure the company remains compliant with Regulatory Body requirements, specifically FDA 21 CFR, Part 11.