Computer Systems Validation Engineer

As a member of the Software Quality Assurance (SQA) team in the Software Engineering group, the Computer Systems Validation Engineer will be a key contributor to the validation activities for medical device and quality system computer systems, including off-the-shelf and custom-built software. The Software Validation Engineer will participate in all phases of the Computer System Validation Lifecycle and will create, review and update Requirements Documents and Functional Specifications, create and maintain test protocols (both manual and automated) and traceability matrices, execute protocols, report issues and defects, summarize results, and complete Validation Reports. The Validation Engineer is expected to have prior software testing experience in an FDA regulated environment and to have participated in the release cycle for shipped products. This is a position with significant opportunity for growth within an innovative and dynamic cancer diagnostics company. - Attend design and functional review meetings - Perform assigned validation activities, including creation of validation documentation and execution of test protocols, for complex laboratory systems, in accordance with the Validation Plan and other established policies and procedures - Maintain all test documentation - Document deviations, system failures, and corrective actions - Follow-up on reviewers' comments, deviations, and technical issues and work closely with Software Development teams to ensure timely resolution - Participate in the creation of Computer System Validation Plans and Risk/Hazard Analyses - Participate in the review of change requests to evaluate validation impact and support re-validation events - Full understanding of the Computer System Validation Lifecycle, regulatory expectations, and associated documentation - Experience testing laboratory information systems in a biotechnology or pharmaceutical setting - Proven experience with defect tracking and source control tools - Excellent problem solving and analytical skills - Excellent verbal and written communication skills - Hands-on experience/training with automated testing tools is desired - Participation in several release cycles for a shipped product is desired - Hands-on experience with databases (writing complex queries to retrieve, insert, update and delete from tables, ability to understand complex database schemas) is desired   REQUIRED EXPERIENCE: - 4+ years experience in Computer Systems Validation in the biotechnology or pharmaceutical industry - BS in Computer Science, Engineering or other technical field If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=503235-3-533 Reference Code: 1275 View all "Genomic Health" jobs