Senior Process Engineer I

Role: Sr. Process Engineer responsible for optimizing and sustaining manufacturing processes within a regulated biopharma environment, leveraging lean and six sigma methodologies to improve efficiency, quality, and cost. Responsibilities: develop cross-functional collaborations across EHS, quality, regulatory, and manufacturing; lead process validation and change management activities; analyze process data to enhance yields and reduce scrap; conduct root cause investigations and implement CAPA; drive process improvements and cost savings projects; ensure documentation accuracy and compliance with GMP, ISO, EU MDR, and other regulations; lead cross-disciplinary teams on process and product projects; develop training programs. Requirements: Bachelor’s in engineering with 5+ years of experience or Master’s with 3+ years; expertise in statistical process control (SPC, Minitab), lean six sigma, and project management; strong communication, organizational, and interpersonal skills; familiarity with ERP (SAP), MS Office. Preferred: PMP certification. High-Value: experience in biopharma manufacturing, process validation, lifecycle management, and adherence to GxP and regulatory standards. Work setup: role involves regular site presence, travel domestically and internationally, handling biohazardous materials, and operating manufacturing tools and systems. The position supports process and product lifecycle management in a regulated manufacturing setting, contributing to continuous improvement and compliance.