Engineer II, Process Engineering

Role: Process Engineer responsible for optimizing and sustaining manufacturing processes in a regulated biopharma environment. Objectives include improving process efficiency, quality, and cost through lean and Six Sigma methodologies, supporting lifecycle management, and ensuring compliance with GMP, FDA, ISO, and other regulatory standards. Responsibilities encompass cross-functional collaboration with EHS, quality, regulatory, and development teams; executing validation studies; analyzing process data to enhance yields and reduce scrap; and implementing process improvements. Qualifications include a Bachelor’s in Engineering or similar with 0-2 years’ experience; familiarity with statistical process control, lean Six Sigma, and process validation tools preferred. High-value details: role supports manufacturing of biopharma products, requiring adherence to GMP and other industry standards; involves process validation and lifecycle management; tools include ERP (SAP), statistical software (Minitab), and QMS platforms; cross-functional interaction spans quality, regulatory, R&D, and production teams. Location and travel specifics are not provided.