Assess and process validation protocols
Reporting and Analytics
Updating procedures and work instructions
Draft and update manufacturing specifications and procedures
Draft protocols & completion reports.
Working Statistical knowledge
Knowledge about endotoxins is a plus
Ability to map manufacturing processes.
A degree in Engineering and Science - highly preferred
5 - 10 years of Engineering Experience
Strong MS office experience
Experience with statistical analysis tools such as minitab a plus
6 Sigma experience would be a plus
Data Analysis experience
Experience with process validation on medical devices
This position will require travel between 10 - 20 % (both domestic and international)
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