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Sr. Validation Engineer

Replimune Group INC - San Francisco, CA

Posted Jul 24, 2019

Benefits

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About this role

Sr. Validation Engineer San Francisco, CA Overview: Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient's lives depend on it. We imagine a world where cancer is a curable disease. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold and Innovative. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other. People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients. Join us, as we reshape the future. Job Summary: The Senior Validation Engineer will work as part of a larger validation team to ensure the biotech facility equipment, utilities, processes, instrumentation and computerized systems are qualified and maintained in a validated state in accordance with appropriate regulatory guidance. The role requires the individual to be a Validation subject matter expert (SME) responsible for authoring validation protocols, reports and associated documentation. The individual will be responsible for coordinating the scheduling, execution, and review of qualification protocols and reports with internal customers / personnel and external contractors. The Sr. Validation Engineer is responsible for performing / supporting change control assessments, risk assessments, data

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