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Validation & Verification Engineer

Company: Sierra Solutions Group
Location: Hayward
Posted on: September 25, 2022

Job Description:

Job SummaryWe are looking for a Validation and Verification Engineer on behalf of our Pharmaceutical client in the San Francisco area. Primary ResponsibilitiesThe Validation Engineer will be responsible for testing, developing, and executing the complete validation documentation package for a TrakSys MES upgrade project. Education and Experience 5+ years of experience in computer systems validation (CSV), medical device testing within GMP/GxP regulated environmentsProven experience developing a complete validation documentation package of requirements, validation plan, test protocols, dry-run testing, traceability matrix, and validation summary reportStrong understanding of the GAMP5 Validation model, FDA 21 CFR Part 11 requirements, risk-based validation approach, and medical device regulationsMust be able to work closely with Project / System stakeholders and other validation engineering team membersMust have experience with the validation of Manufacturing Execution System (MES), ideally Traksys but open to other MESMust have experience with relational database systems, such as MS SQL, My SQL, and Oracle, and write basic SQL queriesMust have experience testing and validating different GAMP categories of software such as custom, embedded, and firmware-based software applicationsMust have experience using Jira for writing test cases, issue tracking, version release, and other testing activityGeneral understanding of SDLC, Waterfall & Agile software development methodologiesNice to have experience with test automation suites and framework developmentNice to have working experience in a medical device manufacturing facility

Keywords: Sierra Solutions Group, Hayward , Validation & Verification Engineer, Engineering , Hayward, California

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