Responsibilities include guiding a team of validation engineers, creating validation deliverables, guiding the team in preparing Validation deliverables, work on remediation activities and validation projects and effectively meeting customer expectations. Managing validation efforts and drafting, reviewing, approving, executing various validation lifecycle stages; from business need through design, construction, testing and implementation in accordance with FDA validation standards. Perform Gap Analysis and compliance audits on existing operations and documentation and supporting the client’s development of a remediation plan to address the deficiencies. Develop and update the Requirements Traceability Matrix (RTM) during the QA Testing Phase. Develop test plans, test strategies, test scripts for validation testing along with the Test Summary Report (TSR). Perform Unit Testing, System Testing, Integration Testing, Regression Testing and User Acceptance Testing (UAT) using HP Quality Centre to ensure that the user requirements are met and maintained. Perform Load testing using Load Runner. Develop, modify, and execute test cases utilizing Automatic Testing tools such as, Test Director, WinRunner, and Microsoft Visual Source Safe. Will work in Manchester, CT and/or various client sites throughout the U.S. Must be willing to travel and/or relocate.