Beckman Coulter Diagnostics
Senior QA Validation Engineer
Beckman Coulter Diagnostics, Chaska, Minnesota, United States, 55318
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. By harnessing Danaher’s system of continuous improvement, you help turn ideas into impact—innovating at the speed of life.
The
Senior QA Validation Engineer
is responsible for assisting in the sustainment of a robust Master Validation Plan and support of the MVP strategies. 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. Qualifications
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
Experience in IVD Medical device or Pharmaceutical Manufacturing. ASQ Certification. Benefits & Equal Opportunity
Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or applyassistance@danaher.com.
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Senior QA Validation Engineer
is responsible for assisting in the sustainment of a robust Master Validation Plan and support of the MVP strategies. 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. Qualifications
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
Experience in IVD Medical device or Pharmaceutical Manufacturing. ASQ Certification. Benefits & Equal Opportunity
Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or applyassistance@danaher.com.
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