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Validation Engineer

Company: Danaher
Location: Logan
Posted on: January 16, 2021

Job Description:

Help us improve access to life-changing therapies that can transform human health We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020. Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes. What you--------ll do Quality engineers are responsible for coordination and execution of validation studies in accordance with current Good Manufacturing Practices. Essential responsibilities include: Lead analysis of defect data and CAPA creation / resolution and maintain records as specified by the Cytiva quality system. Interface with Supplier Quality on supplier related defects. Perform Validation for implementation of major and minor software and equipment applications or modules for Good Manufacturing Practices (GMP) use. Write and conduct computer/equipment system/software validations (IQ/OQ/PQ) for manufacturing processes and equipment. Maintain regular contact with customers to ensure products meet expectations. Conduct root cause analysis on product quality issues, identify trends, and communicate with other functional departments for resolution. Reduction of MRB and non-conforming material inventory. Develop, establish, and optimize quality inspection methods, test methods, and product specifications. Ensure compliance through validation and verification (V&V). Who you are Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 5 years of experience in ISO13485 Manufacturing). Familiar with Quality Systems Regulations (such as FDA 21CFR820 & 21CFR210) and International Quality System Standards (like ISO13485). Strong working knowledge of computer programming and systems (Gamp5 or similar). Understanding of computer logic. Strong communication skills, verbal and written. Working knowledge of Excel, Word, Power Point, Minitab, Statistica. Ability to read and understand CAD drawings. Some traveling may be required (less than 10% of time). Desired Characteristics Bachelor--------s degree in engineering or science related field 3 years of quality assurance or quality engineering experience Green Belt Certified CQE Certification Knowledge of 5S and Lean Manufacturing experience Strong working knowledge of Current Good Manufacturing Practices (cGMP) Demonstrated ability to lead Process management skills Additional Eligibility Requirements Cytiva will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen. Who we are Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you--------ll feel right at home here. If you--------re flexible, curious and relentless, you--------ll belong. If you are excited about a global culture, this can be the place to further your career. Want to know more? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page Cytiva is a 3.3 billion USD global life sciences leader with nearly 7000 associates across 40 countries who are dedicated to our mission to advance and accelerate therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients. Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The -------EEO is the Law----- - poster is available here .

Keywords: Danaher, Logan , Validation Engineer, Engineering , Logan, Utah

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