Requires thorough understanding of System Development Life Cycles for FDA regulated applications.Must be experienced in developing Computer System Validation deliverables for FDA-regulated applications: Validation Plans, Requirement Specifications, various levels of software testing scripts (IQ, OQ, PQ), Traceability Matrix, and Validation Reports. Requires thorough knowledge of US CFR 21 Part 11 regulations. Requires working knowledge of at least one of the following: US CFR 200 or 300 or 800 series. Experienced with high volume application testing environment. Understanding of Sarbanes-Oxley (SOX) regulations is a plus. Experience with automated Software Testing tools is a plus. Familiarity with QA Auditing is a plus. Familiarity with a Corrective and Preventative Action program is a plus. Non-Technical: Experienced in working within an FDA regulated environment for the Pharmaceutical and/or Medical Device industries. Requirements   Ability to work within a Project Team setting. Ability to guide a project team through the validation process. Track, schedule and manage validation issues to ensure commitment dates are met. Jointly develop, communicates plan with project team. Insure timely flow of information with project team. Manage validation Project Plan. Responsible for tracking, coordination, and project planning of Computer System Validation activities. Methodology/Certification: Bachelor Degree in Chemistry, Mathematics, Engineering or Computer Science. Advanced course work in technical systems or continued education in technical disciplines is a plus.