About OnShore Technology Group

For over 15 years, we have worked as a trusted partner with our clients as well as many global system integrators and technology companies to help deliver turnkey validated systems and ensure sustained compliance.

OnShore’s leading innovation is ValidationMaster™, the first Enterprise Validation Management System (EVMS) of its kind to include a validation Kanban board and seamless integration with our unique ValidationMaster Quality and Risk Management portal.

Sr. Validation Test Manager

LOCATION:

Chicago, Illinois, USA

ABOUT THE POSITION

The Validation Test Manager leads a team of Subject Matter Experts (SMEs) in the development, execution, and documentation for cloud and on-premise validated computer systems including but not limited to ERP, CAPA, document management, DHR, plant maintenance, labeling and other quality management systems as required.

ROLES & RESPONSIBILITIES

  • Management and oversight of end-to-end validation testing program
  • Review test estimates, strategy and approach for IQ/OQ/PQ and Cybersecurity Qualification (CyQ)
  • Development of Validation Test Plans
  • Establish practices that enable culture of continuous improvement and lean validation processes
  • Coordinate volume/stress/load testing activities
  • Participation in defect (incident)triage meetings
  • Management of automated testing environment
  • Tracking of testing milestones, dependencies, issues, risks and assumptions

EDUCATION & CERTIFICATION

  • B.S. or equivelent in computer science, engineering, life sciences or related field
  • Minimum of 10 years experience in software quality and testing
  • Advanced knowledge of automated testing tools and best practices
  • Experience in testing cloud technologies / platforms
  • Excellent interpersonal skills
  • Strong oral and written communication skills in English
  • Working knowledge of Microsoft Project and PMBOK project management practices
  • Prior experience/participation in regulatory audits is preferred

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