Verification and Validation Specialist
1 week 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 with minimal oversight, working with multidisciplinary teams to design, construct, and execute engineering, verification, and reliability tests and protocols.
Key Responsibilities:
- Lead verification and validation projects to support site and department initiatives.
- Work with engineering teams to design, construct, and execute 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.
- Support change control processes through assessment of system changes and identifying the extent of qualification or re-qualification activities as needed.
- 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.
- Comply with design control guidelines and quality requirements within the company's regulated ISO/FDA environment.
Requirements:
- 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.
- Medical Device field experience is a plus.
- Strong troubleshooting skills.
- Systems Engineering and integration skills with demonstrated relevant experience over the full product development cycle for a complex electromechanical system.
- Must be able to work independently, manage time to work on several simultaneous projects, participate on risk assessment teams, and learn/apply new verification and validation methodologies.
- Knowledge of electro/mechanical production processes.
- Technical skills in relevant Manufacturing Engineering disciplines.
- Knowledge of FDA, QSR, and ISO quality systems.
- Strong collaborative and communication skills.
- Exceptional attention to detail.
About bioMerieux Inc.
bioMerieux Inc. is a world leader in the field of in vitro diagnostics for over 60 years, providing diagnostic solutions that determine the source of disease and contamination to improve patient health and ensure consumer safety. We have a global presence with over 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.
We offer a range of benefits, including low-cost medical, dental, and vision benefits, 11 paid holidays, 160 hours of paid time off, annual bonus, 9.5% 401k company contribution, tuition reimbursement, and an onsite cafeteria with daily food stipend.
Join our team and be part of a family-owned global company with a long-term vision and a human-centered culture.
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