Senior Process Engineer

Role: Senior Process Engineer specializing in Downstream Process engineering within Amgen's advanced drug substance manufacturing facility. Objectives: support the design, commissioning, validation, and ongoing operation of biopharmaceutical process equipment, ensuring GMP compliance and process reliability. Responsibilities: provide system ownership for bioprocess equipment, implement equipment improvements, support technology transfers and new product introductions, develop maintenance and risk management strategies, and collaborate with manufacturing, quality, process development, and regulatory teams. Qualifications: PhD or Master’s degree with 2+ years, or Bachelor’s with 4+ years in engineering; extensive experience in biopharma manufacturing, particularly downstream unit operations such as chromatography, centrifugation, and filtration; knowledge of GMP, validation, and capital project management; strong analytical, leadership, and communication skills. Preferred: background in chemical or mechanical engineering, 6+ years’ industry experience, familiarity with GMP bioprocess equipment, and experience with engineering solutions in regulated environments. HighValue: biopharmaceutical manufacturing, downstream processing, GMP compliance, process validation, process optimization, equipment troubleshooting, and safety protocols. WorkSetup: flexible schedule supporting 24/7 operations, with ~10% domestic/international travel.