Staff Software Validation Scientist

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Staff Software Validation Scientist','DIA008964','!*!Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.','!*!Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.','!*!The Staff QA Scientist – Software Validation will be a member of the team responsible for the training, mentoring, and oversight of validation-related activities. The individual will assist in the sustainment of a robust Master Validation Plan and support of the MVP strategies. The individual will be responsible for understanding customer (internal and external) requirements, and with minimal guidance, developing test cases and validation-related documents and procedures especially in the area of non-product software qualification. Working knowledge of computer controlled and automated equipment qualification is required. Their major responsibilities will entail:The training and mentoring of individuals and validation teams to ensure efficiency and compliance in both formal (classroom style) and informal training Adherence to defined corporate and local validation practices and procedures while monitoring the state of the industry to ensure that BEC utilizes current best practices.','!*!Educational Requirements:Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences or other relevant baccalaureate degree and 6 years of relevant experience, or Master’s degree(s) and 4 years of relevant experience, or PhD and 2 years of relevant experience. ASQ CQE/CSQE and experience in the medical device industry strongly preferred.The candidate should have the following skills:At least 10 years direct experience doing computerized-systems/software validations, including: gathering/generating user requirements, and writing and executing testing using Good Documentation Practices for the entire lifecycle of at least 100 unique systemsWorking knowledge of 21 CFR 820 and 21 CFR Part 11 requirementsExperience implementing site validation requirements changes in a 24/7 business environment, and how to train a culturally diverse siteKnowledge and experience applying risk-based validation philosophy to computerized-systems and software in the Pharma or Medical Device industryAbility to quickly and adequately assess technology to ascertain the necessary validation elements for computerized-systems and software to ensure compliance to company policies and procedures, and national and international regulationsDemonstrated skill working with Microsoft Windows Operating Systems, including XP and 7 (NT, 2000, 8.1 a plus) and Office products, versions 2003, 2010, 365, and 2013 (2016 a plus)Demonstrated ability to collaborate with various IVD Medical Device business roles, such as: Quality Assurance, Quality Systems, Mfg./Operations, etc.','!*!Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries. A globally diverse team of 71,000 associates, we are united by our culture and operating system, the Danaher Business System, which is our competitive advantage. In 2014, we generated $19.9B in revenue and our market cap exceeded $60B. We are #149 on the Fortune 500 and our stock has outperformed the S&P; 500 by more than 2,000% over 20yrs.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.','!*!Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries. A globally diverse team of 71,000 associates, we are united by our culture and operating system, the Danaher Business System, which is our competitive advantage. In 2014, we generated $19.9B in revenue and our market cap exceeded $60B. We are #149 on the Fortune 500 and our stock has outperformed the S&P; 500 by more than 2,000% over 20yrs.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.','Beckman Coulter','Quality','North America-United States-MN-Chaska','','Full-time','Staff Software Validation Scientist

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