Senior QA Validation Engineer jobs in United States
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Beckman Coulter Diagnostics · 2 days ago

Senior QA Validation Engineer

Beckman Coulter Diagnostics is a global leader in clinical diagnostics committed to innovating for tangible impact in life sciences, diagnostics, and biotechnology. The Senior QA Validation Engineer is responsible for assisting in the sustainment of a robust Master Validation Plan and supporting MVP strategies, including training and mentoring validation teams, generating test cases, and executing test procedures.

BiotechnologyHealth DiagnosticsLife ScienceManufacturing
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H1B Sponsor Likelynote

Responsibilities

Train and mentor individuals and validation teams (both formal classroom and informal) to ensure efficiency and compliance with validation regulations and corporate procedures
Evaluate specifications for requirements and ensure they meet validation standards
Generate test cases and procedures from specifications with minimal guidance
Execute test procedures with minimal guidance and document results accurately
Apply Danaher Business System tools to make continuous improvements across the business

Qualification

Computer System ValidationFDA regulationsISO standardsGxP guidelinesValidation methodologiesTrainingTest case generationContinuous improvementIVD Medical device experienceASQ CertificationMentoring

Required

Bachelor's degree in a relevant field with 5+ years of experience, OR Master's degree in a relevant field with 3+ years of experience, OR Doctoral degree in field
Experience in software, test method, equipment, process, and/or design testing methodologies
Knowledge of FDA regulations, ISO standards, and GxP guidelines
Experience with Computer System Validation (CSV) and process validation

Preferred

Experience in IVD Medical device or Pharmaceutical Manufacturing
ASQ Certification

Benefits

Paid time off
Medical/dental/vision insurance
401(k)

Company

Beckman Coulter Diagnostics

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A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 80 years.

H1B Sponsorship

Beckman Coulter Diagnostics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (27)
2023 (27)
2022 (38)
2021 (26)
2020 (32)

Funding

Current Stage
Late Stage
Total Funding
unknown
2011-02-07Acquired

Leadership Team

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Ruth Lyons
VP North America Marketing
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Company data provided by crunchbase