Validation & Verification Engineer

Job Description

ONSITE(3 days per week onsite required)

This is an on-site position located in Hayward, CA with some flexibility of working remotely (3 days per week onsite required*)

The Validation Engineer will be responsible for testing, developing, and executing the complete validation documentation package for a TrakSys MES upgrade project.

5+ years of experience in computer systems validation (CSV), medical device testing within GMP/GxP regulated environments

Proven experience developing a complete validation documentation package of requirements, validation plan, test protocols, dry-run testing, traceability matrix, and validation summary report.

Strong understanding of the GAMP5 Validation model, FDA 21 CFR Part 11 requirements, risk-based validation approach, and medical device regulations.

Must be able to work closely with Project / System stakeholders and other validation engineering team members.

Must have experience with the validation of Manufacturing Execution System (MES), ideally Traksys but open to other MES

Must have experience with relational database systems, such as MS SQL, My SQL, and Oracle, and write basic SQL queries.

Must have experience testing and validating different GAMP categories of software such as custom, embedded, and firmware-based software applications.

Must have experience using Jira for writing test cases, issue tracking, version release, and other testing activity

General understanding of SDLC, Waterfall & Agile software development methodologies

Nice to have experience with test automation suites and framework development.

Nice to have working experience in a medical device manufacturing facility.

Must Have Skills