Principal Manufacturing Systems Engineer – Upstream/Downstream Process Automation

Role: Principal Manufacturing Systems Engineer specializing in automation for biopharmaceutical upstream and downstream processes at Amgen's advanced drug substance manufacturing plant. Responsibilities include supporting site design, construction, start-up, and operational readiness; leading automation commissioning, qualification, and validation aligned with GMP standards; providing ongoing automation support for 24/7 manufacturing operations; implementing continuous improvement initiatives; and serving as a site automation expert. This role collaborates closely with corporate engineering, quality, process development, and manufacturing teams, and represents the site in global automation forums. Requirements: Doctorate with 2+ years, Master’s with 4+ years, Bachelor’s with 6+ years, or equivalent experience in engineering, with at least 2 years in a managerial or team lead role. Preferred qualifications include expertise in Emerson DeltaV, process control networks, real-time process monitoring (e.g., PAT), and familiarity with industry standards like GAMP, GMP, 21 CFR Part 11. High-value biopharma specifics encompass experience with bioprocessing (upstream seed train, bioreactors; downstream chromatography, filtration), and knowledge of regulated environments, validation, tech transfer, and process design. The role involves up to 10% domestic/international travel, supporting a cutting-edge facility with embedded Industry 4.0 capabilities, sustainability initiatives, and operational excellence in biologics manufacturing.