Contract position: Global leader in the healthcare/medical product manufacturing industry is looking a Validation Engineer in St Paul MN to conduct Data Integrity Gap Assessments of Manufacturing and Laboratory systems to provide remediation actions for part 11 compliance. This is a contract position expected to last 10 months, could be longer based on performance. Currently we are only looking for local candidates. Great Contractor Benefits! Apply Now!
Responsibilities for the Validation Engineer
- Work with a small team and define Validation requirements and documentation to be used for Application/System qualification
- Develop protocol and unit/system test cases, scripts and plans
- Facilitate testing activities within the team and across IT groups
- Responsible for cross functional/ business integration testing and documentation
- Understand and follow appropriate Software Development Life Cycle (SDLC) quality validation processes
Requirements for the Validation Engineer
- B.S.in Engineering
- Minimum of 3 years of Computer System Validation (CSV) or Data Integrity (DI) experience within a life sciences manufacturing and/or laboratory environment
- Experience with manufacturing and lab qualification and operations in a cGMP environment
- Direct experience in the execution of validation protocols
- Knowledge of current industry standards such as GAMP5 and ASTM E2500
- Paid Vacation
- Health Insurance, and more...