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Join Our Process Development Team At AbbVie's Process Development team, we are dedicated to pioneering advancements in the field of tissue products. Our highly collaborative group focuses on developing innovative manufacturing processes that support both clinical and commercial applications. We're seeking driven and talented individuals to join us in transforming scientific discoveries into tangible health solutions. Role: Senior Process Development Engineer * Designs and develops processes for manufacturing clinical and commercial tissue products, using statistics-based experimentation and principles of process excellence. * Investigates and evaluates existing technology; designs and implements new methodologies, materials, machines, processes, or products. * Conducts appropriate studies to demonstrate the ability of the product/device to function as intended (i.e., verification and validation process). * Develops study protocols, technical reports, new process Standard Operating Procedures (SOPs), batch records, and other documents as required, including the necessary documentation to support regulatory filings such as 510k, IDE, and PMAs. * Identifies outside vendors and consultants to ensure the delivery of raw material, equipment, supplies, or services needed to meet scheduled timelines. * Interfaces with various departments to ensure processes and designs are compatible for new product technology transfer. * Serves as technical leader and establishes project level timelines with project teams. * Provides technical support to manufacturing and quality as needed. * Monitors the performance of processes and equipment and makes recommendations for continuous improvement.
