Principal Manufacturing Systems Engineer

Role: Principal Manufacturing Systems Engineer leading global manufacturing technology initiatives at Amgen, focusing on optimizing biotech production processes through advanced automation and digital platforms. Responsibilities: manage large capital projects within GMP environments using Agile methodologies, oversee the deployment and lifecycle of core systems such as Aveva Pi, DeltaV, Rockwell, and MES; partner with site and corporate stakeholders to prioritize demand, manage budgets, resources, and vendor performance; establish global standards and best practices for manufacturing technology; ensure compliance with GMP, data integrity, and regulatory requirements; lead cross-functional teams including Quality, IT, Automation, and external system integrators; own the operations technology roadmap including upgrades, standardization, and harmonization; report program status to senior leadership. Requirements: advanced degree (Doctorate, Master’s, Bachelor’s) with 2-6+ years in manufacturing automation or information systems, preferably in biotech or pharma with GxP experience; strong knowledge of manufacturing systems (Aveva Pi, DeltaV, MES), industry standards (GAMP, 21 CFR Part 11), and Agile project management; excellent communication skills and ability to lead cross-functional teams. Preferred: experience with product ownership or Scrum Master roles, integration of OT platforms with enterprise systems, and project finance expertise. High-Value: biotech manufacturing, process automation, GMP compliance, global project execution, and cross-functional leadership in a fast-paced biotech environment.