Principal Manufacturing Systems Engineer
Core
Lead the delivery of Information Systems and Automation projects for Amgen's advanced drug substance manufacturing plant, integrating Industry 4.0 capabilities to support biotech operations.
Role type
Principal Manufacturing Systems Engineer (IS/Automation)
Builds
IS/Automation projects, PCS/MES implementations, and integrated control systems for pharmaceutical manufacturing.
Domain
Biotechnology / Pharmaceutical Manufacturing / Industrial Automation
Deliverable
production ML models | product features | infrastructure
Required skills
Portfolio planning and risk management, cross-system feasibility analysis, functional design from business needs, strategic technology translation, vendor and stakeholder management, GAMP software development lifecycle, ANSI/ISA-S88 and S95 standards, validation and change control methodology, troubleshooting computerized systems.
Preferred skills
Pharmaceutical/Biotech manufacturing experience, Emerson Delta V Platform, Rockwell FactoryTalk/PLC, Aveva PI Data Historian, Korber MES, C&Q documentation, PAT/APC/IIoT technologies, 21 CFR Part 11, cyber security for OT.
Technologies
Emerson Delta V, Rockwell FactoryTalk, Rockwell PLC, Aveva PI, Korber MES
Responsibilities
Own delivery of IS/Automation portfolio with resource and financial management; anticipate and resolve simultaneous project issues; perform cross-system assessments and scope projects; translate strategic opportunities into executable plans; manage relationships with peers, service owners, and vendors; communicate issues and solutions across organizational levels; elicit and analyze business customer needs to convert into functional design.
Seniority
Principal, hands-on IC with strategic oversight
