Responsible for supporting the AMI Validation Manager with all process validation related support for the life cycle development and manufacturing of Class I, II and III medical devices.
Essential Duties and Responsibilities:
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor’s degree required preferably in an Engineering or Science discipline. At least three years of Process Validation work experience required, preferably within a Medical Device Company. .
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Knowledge of testing equipment, statistical methods, control plans.
Knowledge of cGMP and GDP requirements.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), SAP or similar inventory software and Minitab.