About OnShore Technology Group, Inc.
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