Process Improvement Engineer I

Role: Process Development Engineer supporting manufacturing improvements and new product transfer at a molecular diagnostics company focused on infectious disease testing. Responsibilities: optimize existing manufacturing processes for quality and efficiency, investigate non-conformances, develop and validate process and equipment qualifications, and support scaling, transfer, and validation of new products. Collaborate with Product Development, ensure regulatory compliance, and prepare manufacturing documentation. Requirements: B.S. in Engineering (Chemical, Mechanical, or Manufacturing preferred); 1-2 years experience in process development for biological or chemical products, preferably diagnostics or medical devices; knowledge of process validation, GxP, and regulatory standards; proficiency in Microsoft Office and familiarity with process validation, statistical tools, and project management. Preferred: experience with process transfer, SAP, Six Sigma, and mechanical design (SolidWorks). High-Value: experience in manufacturing process improvement, validation, and transfer for molecular diagnostics or infectious disease products, with a focus on quality, regulatory compliance, and scalable processes. Work setup includes potential for hybrid or remote work with limited travel support to Bethlehem, PA sites.