Position Overview. Elutia is seeking a hands-on Process Quality Engineer to drive quality activities supporting the transfer, scale-up, and commercial manufacture of innovative drug-eluting biological products in a small, fast-paced environment. This role will partner closely with Operations and R&D to help translate development processes into robust, controlled, and scalable manufacturing processes. The Process Quality Engineer will support process characterization, design and execute process studies, evaluate manufacturing changes, troubleshoot process issues, and apply sound risk-based Quality judgment to ensure appropriate controls are established and maintained. The role will also support execution and continuous improvement of Quality Management System processes, including change control, nonconformance and deviation management, CAPA, document control, supplier quality, and audits.

How You'll Contribute:

Process Quality Engineering & Scale-Up Partner with Operations and R&D to support development, scale-up, transfer, and implementation of manufacturing processes. Provide Quality Engineering input to process optimization, characterization, scale-up, technology transfer, and commercialization activities. Help identify critical process parameters, sources of variability, and process controls. Contribute to technically sound and appropriately scoped studies to evaluate process variables, equipment, materials, manufacturing changes, and scale-up risks. Support equipment and process qualification and validation, including

IQ/OQ/PQ

activities.