Qualifications:
Education: Bachelor’s degree (Life Science, Engineering, Biology, Biochemistry) or equivalent validation/GMP job experience
9 or more years of validation experience (or equivalent experience) in a cGMP environment with increasing levels of responsibility for a wide range of validation projects including validation of large-scale biochemical manufacturing, utility and automation systems
General Qualifications for Medical Devices Expert
Responsibilities:
- USP seeks Manufacturing Process Validation expert(s) that would spend time at the site gathering knowledge and information and then assess documents to meet industry standard requirements
- The Process Validation expert is responsible for supporting the LMIC manufacturer(s) in defining qualification/validation strategies and coordinating testing activities required to complete assigned projects in support of the operation of the Manufacturing Facility
- Performance of such validation activities includes Equipment/Utility/Facility Qualification, and Cleaning Validations
