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Job Description

Shire Human Genetic Therapies, Inc. is seeking a Senior Process Validation Engineer II in Lexington, MA with the following requirements: Master’s degree in Pharmaceutical Manufacturing, Bioprocess Engineering, Chemistry, Biochemistry or related field or foreign academic equivalent plus 5 years of experience. Prior experience must include: Perform validation of processes and qualification of equipment for Biologics manufacturing operations; independently determine validation requirements applying risk assessment principles and industry standards; generate, plan, execute and document validation studies per regulatory guidelines; author content for regulatory submissions to support Biologics licenses.

Apply on-line at www.takedajobs.com and search for Req # R0088034.

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