Position Overview
Job Title: Project Validation EngineerJob Description
The Project Validation Engineer leads process validation activities for medical device manufacturing, ensuring that production processes, equipment, and automation systems are robust, compliant, and ready for release to production. This role combines hands-on work on the manufacturing floor with extensive documentation, protocol development, and collaboration across Quality, Manufacturing, and Engineering teams to support innovative, life-saving medical devices.
Responsibilities
+ Develop, author, and execute validation documentation, including IQ/OQ/PQ protocols, process validation plans, procedures, reports, engineering studies, and risk-based documentation.
+ Partner closely with Quality, Manufacturing, and Engineering teams to draft, review, execute, and obtain approval for all validation deliverables.
+ Evaluate manufacturing processes to understand product requirements, process flow, critical p...