$85,000 - $120,000 yearly
Plas-Tech Engineering
Lake Geneva, WI, USA
*Job Summary* The Validation Engineer is responsible for all aspects of validation engineering, with a primary focus on scientific injection molding using electric presses. This role covers IQ/OQ/PQ activities, validation deliverables, and project management to ensure compliance with FDA, ISO 13485, and customer requirements. The engineer will be responsible for developing and maintaining molding guidelines and optimizing processes for efficiency, quality, and productivity. Also to ensure production feasibility, implement manufacturing strategies, and investigate root causes. This person will establish procedures, support new product launches, verify processes, troubleshoots and assists production areas as needed. *Key Responsibilities* * Develop, execute, and document IQ/OQ/PQ protocols for equipment, processes, and software. * Ensure validation practices meet FDA/medical regulatory requirements and customer specifications. * Maintain validation master plans, periodic reviews,...