Software Validation/Test Engineer III

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Software Validation/Test Engineer III - Flow Cytometry and Microscopy

About Thermo Fisher Scientific

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join a team that enables our customers to make the world healthier, cleaner, and safer. Embrace a collaborative environment that champions curiosity, innovation, and scientific perfection. Together, we push the boundaries of technology to empower scientists in making groundbreaking discoveries.

Position Summary

We are seeking a dedicated and skilled Validation Scientist to lead all aspects of the biological validation of new features and capabilities built for flow cytometry (including spectral flow cytometry) and microscopy instrument software.

We are looking for a candidate with a strong background in Immunology and Cell Biology, as well as practical experience in crafting and completing detailed biological studies. This role bridges biology and software, requiring a motivated individual who is enthusiastic about applying scientific knowledge to evaluate and validate advanced analytical and software tools.

The successful candidate will demonstrate agility, collaboration, and attention to detail to ensure seamless product validation aligned with business and compliance requirements.

Key Responsibilities

• Independently develop, strategize, and carry out medium to intricate biological experiments to confirm new functionalities in flow cytometry and microscopy platforms.
• Develop comprehensive validation strategies in close collaboration with Product Owners, Developers, and Domain Testers to align with product development goals.
• Apply knowledge in the fields of Immunology and Cell Biology to develop validation assays that are biologically relevant, guaranteeing product accuracy and scientific integrity.
• Show strength in spectral panel design, including selection of appropriate fluorophores for multi-color flow cytometry.
• Possess a thorough understanding of fluorescence compensation and spectral unmixing techniques to ensure high-quality data interpretation in spectral flow cytometry.
• Engage with software development teams to understand new functionalities and ensure biological validation is robust and comprehensive.
• Carry out effective validation tasks with outstanding quality and accurate completion to drive business breakthroughs.
• Benchmark Thermo Fisher systems against competitor products to identify strengths and opportunities for improvement.
• Show excitement for working in an environment passionate about software, using biological knowledge to assess and improve software products.
• Mentor and guide junior scientists in experimental design, troubleshooting, and documentation practices.
• Work well with global multi-functional teams to plan, implement, and deliver validation outcomes seamlessly.
• Adhere to all data compliance and audit requirements, maintaining traceable and auditable validation documentation for each product release.
• Prepare detailed validation reports and summaries to support product release decisions and regulatory compliance.

Minimum Qualifications and Experience

• Master's or Ph.D. in Immunology, Cell Biology, Biotechnology, or a related Life Science discipline.
• Possessing more than 5 years of practical experience in flow cytometry (including spectral flow cytometry) and conducting assays using microscopy.
• Demonstrated capability to autonomously develop, implement, and analyze intricate biological validation experiments.
• Strong understanding of Immunology and Cell Biology concepts and their application in experimental validation.
• Proficiency in developing spectral panels and optimizing fluorophores for flow cytometry with multiple colors.
• Familiarity with flow cytometry software platforms and competitor systems (e.g., BD, Cytek, Beckman Coulter).
• Displayed excitement for contributing to the software and life science technology industry, combining biological expertise with digital product validation.
• Strong collaboration skills with experience working across global and multidisciplinary teams.
• Excellent analytical thinking, problem-solving, and communication skills.
• Ability to manage multiple projects simultaneously while maintaining compliance and quality standards.
• Commitment to Thermo Fisher's values of Integrity, Intensity, Innovation, and Involvement.

Preferred Qualifications

• Experience in software or hardware validation within the life sciences instrumentation industry.
• Familiarity with regulatory and quality system requirements (e.g., ISO, FDA, 21CFR part11).
• Prior experience mentoring junior team members and contributing to process improvements.

What We Offer

At Thermo Fisher Scientific, our people share a common set of values-Integrity, Intensity, Innovation, and Involvement-that drive our success. We offer competitive compensation, ongoing development opportunities, and a chance to be part of a passionate organization that is sculpting the future of science and technology.