Computer Systems Validation Lead

At least 10 years of experience supporting and/or performing all aspects of computer systems validation activities including development of scalable validation strategies, documents, and perform document reviews At least 7 years prior experience in computer systems validation within GMP/GxP regulated environments Proven experience developing full validation documentation and testing protocols within the various SDLC phases that is scalable and maintainable to demonstrate continuous compliance Experience with FDA 21 CFR Part 11 Experience with the validation of Enterprise systems SAP and/or MES system Preferred. Validation of Life sciences systems such as Veeva, Trackwise, Argus, Clnical, Quality systems highly desired. Broad understanding of the test management Tools, including experience and knowledge Microfocus ALM, ValGenesys etc preferred. Knowledge and experience around CSA highly preferred.