Manufacturing Systems Engineer: Automation

Role: Manufacturing Systems Engineer specializing in automation for biopharmaceutical drug substance production. Main objectives include developing, maintaining, and supporting process control systems within a GMP environment to ensure efficient, compliant operations at Amgen's advanced drug substance manufacturing facility. Responsibilities encompass designing automation solutions using Emerson DeltaV DCS, collaborating with stakeholders to meet process requirements, supporting validation and data integrity assessments, troubleshooting, and driving continuous improvements in automation systems. Qualifications: Bachelor's degree in Electrical, Chemical, or related engineering discipline; typically 2+ years of engineering experience, or equivalent education with more extensive experience. Preferred skills include knowledge of GMP biopharma automation systems, experience with process control hardware/software, especially DeltaV, and familiarity with GAMP, 21 CFR Part 11, and industry automation standards. High-value biopharma specifics involve GMP compliance, process automation for bioreactors, chromatography, viral filtration, and utilities, with an emphasis on quality and regulatory adherence. The role involves cross-functional collaboration with manufacturing, QA, and project teams, supporting commissioning, validation, and continuous improvement efforts. Location: Likely onsite at the new plant with possible remote work options, and involves support for site operations and project execution.