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Must - Haves:

3+ years of process development experience supporting ongoing optimization and improvement in a medical device environment Must have experience designing, validating, and scaling up a cleaning process in a regulated chemical manufacturing environment Developing a Cleaning (CIP) process from scratch is the biggest must have Experience leading and managing new process development initiatives from concept through execution including process documentation and process qualification Expertise in CAD - designing & drafting Understanding of cGxP principles, ISO 13485, ISO 14971, and 21CFR820 BS or MS in Polymer Science, Polymer Engineering, Chemistry or Chemical Engineering

Plusses:

Six-Sigma Green Belt