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.
Numbers & Facts
Location
San Francisco, California
Skills
Biologyunmatched
Code of Federal Regulationsunmatched
Computer Skillsunmatched
Computer Systemsunmatched
Documentation Reviewunmatched
FDA (Food and Drug Administration)unmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
Manufacturing Execution Systems (MES)unmatched
SAPunmatched
Scalable System Developmentunmatched
Software Development Lifecycle (SDLC)unmatched
Strategic Planningunmatched
System Validationunmatched
Test Toolsunmatched
Validation Documentationunmatched
Validation Testingunmatched
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