Associate Engineer, cGMP Computer Systems Validation - Verona, WI

Only for registered members Verona, WI, United States

2 weeks ago

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Job summary

This position will provide validation and lifecycle support for computerized systems software and IT infrastructure within the cGMP GLP
and GCP regulated Quality organization. The incumbent will serve as an SME providing compliance leadership oversight
for CSV projects collaborating with business partners to maintain improve computer system validation processes.


  • Provides quality guidance for CSV efforts related to requirements engineering system risk assessments
  • Reviews approves validation documentation including Validation Plans Requirements Specifications Risk Assessments Functional Requirements Specifications Testing Protocols Requirements Trace Matrices Summary Reports
  • Serves as an SME for CSV maintains knowledge information in the Computer System Validation area of expertise li>

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