Business Systems and Validation Analyst III
Thermo Fisher Scientific · Highland Heights, KY
QualityFull timeCompany career page
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Role summary
Senior analyst supporting validation of laboratory instrumentation and computerized systems across global operations. Responsible for requirements gathering, validation documentation, testing execution, regulatory compliance, and mentoring junior team members within a quality assurance framework.
What they're looking for
- Legal authorization to work in United States without sponsorship
- Ability to pass comprehensive background check and drug screening
- Local to Northern Kentucky/Cincinnati area for hybrid work arrangement
- Advanced knowledge of SDLC processes, validation methodologies, and regulatory frameworks
- Experience with risk assessments, traceability matrices, and validation documentation
- Demonstrated expertise in laboratory software systems and instrumentation validation
What you'll be doing
- Gather and document business, user, and system requirements for laboratory systems and instrumentation
- Lead development and maintenance of validation lifecycle documentation including risk assessments and traceability matrices
- Create, execute, and manage validation test cases and testing activities for laboratory systems
- Support client, regulatory, and internal audits by presenting validation documentation and compliance controls
- Provide technical guidance and mentorship to junior team members on SDLC processes and validation methodologies
Privacy & handoff
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