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Verification and Validation Specialist
2 months ago
At bioMerieux Inc., we are seeking a skilled Verification and Validation Engineer to join our team. As a key member of our engineering team, you will be responsible for leading verification and validation projects, working with multidisciplinary teams to design and execute engineering tests and protocols, and ensuring validation documentation is generated and approved in accordance with procedures.
Key Responsibilities- Lead verification and validation projects with minimal oversight to support site and department initiatives.
- Work with engineering team members to design, construct, and execute engineering tests and protocols.
- Write and execute protocols and test cases for verifications and validations.
- Assure validation documentation is generated, reviewed, and approved in accordance with procedures.
- Collect and analyze data and generate reports.
- Support development of project documentation, including FMEAs, specifications, and plans.
- Participate in technical reviews and support change control processes.
- Maintain configuration management documentation and support instrument prototype builds.
- Support instrument, PCB, and firmware troubleshooting and issue resolution.
- Continuously improve and update the validation program.
- Bachelor's Degree with 5+ years of verification and/or validation experience in a manufacturing environment or Master's Degree with 3+ years of verification and/or validation experience in a manufacturing environment.
- Well-grounded in fundamental engineering design principles and test methods with demonstrated hands-on design competency working with complex medical instrumentation.
- Experience with complex laboratory or engineering test equipment, data acquisition systems, engineering design documentation, and calibration procedures.
- Strong troubleshooting skills and systems engineering and integration skills with demonstrated relevant experience over the full product development cycle for a complex electromechanical system.
- Knowledge of electro/mechanical production processes, technical skills in relevant Manufacturing Engineering disciplines, and knowledge of FDA, QSR, and ISO quality systems.
- Strong collaborative and communication skills, exceptional attention to detail, and ability to work independently and manage time to work on several simultaneous projects.
bioMerieux Inc. is a world leader in the field of in vitro diagnostics for more than 60 years, providing diagnostic solutions that determine the source of disease and contamination to improve patient health and ensure consumer safety. We have more than 6,200 team members across 11 sites or subsidiaries in North America, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.
We are a family-owned global company with a long-term vision and a human-centered culture. We offer a range of benefits, including low-cost medical, dental, and vision benefits starting day one, 11 paid holidays, 160 hours of paid time off, annual bonus, 9.5% 401k company contribution with no vesting period, tuition reimbursement up to $10,000 per calendar year, and an onsite cafeteria with a daily food stipend.