Sr. Validation Engineer at Avantor providing equipment validation expertise in medical device and biopharma manufacturing. Overseeing installation and performance qualification with cross-functional collaboration.
Responsibilities
Provide specialized knowledge in developing the strategy for equipment for processes
Ensure proper installation, operational and performance qualification of equipment
Prepare all protocols and reports for validation work
Oversee and review validation area processes and procedures
Author validation documents and execute validations of equipment
Coordinate and lead validations to assure compliance with customer requirements and regulations
Requirements
BS degree in Engineering or Life Science (Chemistry, Bio, Physics, etc.) preferred
5+ years of experience in Equipment, Cleaning, and/or Process Validation Engineering experience within a pharmaceutical or medical device company
Knowledge of Industrial Quality Control, Quality Engineering, Quality Assurance and Validation
Knowledge of CFRs and their application to Medical Devices
Knowledge of software packages supporting statistical data analysis, word processing, flow charting, and project management
Familiarity with manufacturing methods related to medical devices
Strong communication skills, both verbal and written
Ability to work independently and as a team member
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