Principal Manufacturing Systems Engineer

Role: Principal Manufacturing Systems Engineer in Amgen's advanced biologics manufacturing facility, leading IS/Automation projects to enhance production technology. Responsibilities: deliver portfolio projects with planning, resource, risk, and financial oversight; assess system feasibility, scope, and prioritize initiatives; translate technological strategies into executable plans, ensuring compliance with industry standards like GAMP, ANSI/ISA-S88/S95, and 21 CFR Part 11; manage relationships with internal teams, vendors, and stakeholders; analyze needs and develop functional system designs. Requirements: Doctorate with 2+ years or Master’s with 4+ years, or Bachelor’s with 6+ years experience in Information Systems or Manufacturing Automation; hands-on expertise with Emerson DeltaV, Rockwell FactoryTalk, Aveva PI Data Historian, and related platforms; knowledge of validation, cyber security, and industry standards; strong collaboration and troubleshooting skills. Preferred: biotech/pharma manufacturing background, familiarity with PAT, APC, AR/VR, IIoT, and systems integration within biotech or pharmaceutical environments. The role supports the integration of cutting-edge manufacturing technology in a biologics setting, emphasizing system delivery, compliance, and cross-functional collaboration. Work setup may include onsite and hybrid elements, with a focus on continuous technological advancement.