Process Engineer I

Role: Process Engineer I responsible for understanding, optimizing, and sustaining manufacturing processes within a biopharma setting, applying lean and six sigma methodologies. Objectives include improving process efficiency, workflow, and asset utilization, while ensuring compliance with GMP, FDA, ISO, EU MDR, and other regulatory standards. Responsibilities encompass cross-functional collaboration with EHS, product development, quality, regulatory, and facilities; executing engineering studies, validations, and change controls; conducting statistical analyses to enhance yields and reduce waste; investigating non-conformances, FMEA, CAPAs; and supporting lifecycle and process improvements. Qualifications: Bachelor’s degree in Engineering or Science with 0-3 years relevant experience. Skills include proficiency with ERP (SAP), statistical tools (Minitab/SPC), project management software, and QMS platforms. Experience with manufacturing in sterile or biohazard environments, handling hazardous materials, and working in cleanroom or laboratory settings is essential. High-value specifics: manufacturing of biopharmaceutical products, GMP compliance, validation activities, involvement in lifecycle management, and cross-functional teamwork. Role may require domestic and international travel. Work environment: manufacturing, cleanroom, lab, and office; safety protocols and PPE are mandatory.