When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
The Staff Systems Verification and Validation Scientist will lead the definition, design and execution of system verification and validation activities throughout the product development life cycle at Thermo Fisher Scientific
This will include but not be limited to:
Test method and strategy design; protocol execution; data analysis and communication to project and business stakeholders. The successful candidate will maintain up-to-date knowledge of customer workflows, scientific advancements in qPCR and/or capillary electrophoresis while ensuring proximity to the competitive landscape. In doing so, they will be expected to assist in translating customer needs into product requirements by understanding the broader impact of design features and results to the user and regulator.
He/She will be a pivotal member of the development team and assist in problem solving and troubleshooting to improve current and future products in development. Thus, the individual will be expected to exercise influence across functional teams and provide input to management on strategic decisions.
The successful candidate will possess:
- Typically requires B.S. or M.S. in Molecular Biology, Bioengineering, Applied (Bio)Statistics, Systems Engineering or related scientific discipline with a minimum of 5 years experience in product development for clinical, research, pharma, medical device or other relevant industry
- Extensive hands on experience operating and troubleshooting qPCR and/or capillary electrophoresis instrumentation with knowledge of applications, software, assay development and customer workflows
- Proven ability to execute complex experiments independently, perform in-depth statistical analysis, interpret experimental results, and make sound conclusions
- Proven ability to apply creative problem solving skills to novel or complex applications
- Proven ability to critically evaluate proposed study designs with strong knowledge of statistics, the calculation of sample sizes and/or estimation of statistical power
- Strong interpersonal skills with a proven ability to collaborate with others in a multi-disciplinary team setting, influence decision making, and build group consensus
- Excellent written and oral communication skills
- Demonstrated success leading medium to large sized projects, with the ability to meet technical objectives and solve complex challenges under conditions of ambiguity and rapid change
- MS or PhD degree in Molecular Biology, Bioengineering, Applied (Bio)Statistics, Systems Engineering or in a related scientific discipline
- Experience working within a regulated medical device industry with knowledge or experience in FDA submissions
- Familiar with accreditation and guiding agencies for the clinical laboratory including CAP, CLIA, and CLSI, including experience in audits conducted by accrediting bodies
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com