Validation Engineer

Validation Engineer Location- (REMOTE until COVID passes) Length 12+ Months Start ASAPDiscriptionsApply FDA MHRA and other applicable global health authority regulations to the development of computer systems supporting regulated business processes Follow SOPs and industry best practices Possess Expertise on Good Documentation and Good Testing Practices in order to train those within the business that are less familiar. Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system Review validation deliverables for projects which are contracted to third party suppliers Maintain close communication with stakeholders and team members to keep apprised of computerized system needs impacts on computer validation project validation status and other relevant issues Assist in planning implementing and documenting user acceptance testing • Review computerized systems validation documents such as • Requirements Specification • Design Specification • CSV Risk Assessment • Test Plans • Test Summary Reports • Data Migration Plan • Pre/Post Executed Test Scripts • Traceability Matrix • Release to Production StatementsDirect and review testing Provide guidance on quality issues that affect the integrity of the data or the system Obtain and respond to QA