Computer Systems Validation Lead

Job description

- 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.