Principal Manufacturing Systems Engineer - Amgen North Carolina Site Lead
Core
Lead Information Systems and Automation projects for Amgen's drug substance manufacturing plant, integrating Industry 4.0 technologies to support biopharmaceutical production.
Role type
Principal Manufacturing Systems Engineer (Site Lead)
Builds
Production ML models | product features | infrastructure
Domain
Biotechnology / Pharmaceutical Manufacturing / Industrial Automation
Deliverable
infrastructure
Required skills
Portfolio planning and risk management, Cross-system feasibility analysis, Strategic technology translation, Functional design from business needs, Emerson Delta V Platform coding, Rockwell FactoryTalk/PLC coding, Aveva PI Data Historian, GAMP software lifecycle, ANSI/ISA-S88/S95 standards, Validation and change control methodology, Cyber security for OT networks
Preferred skills
Pharmaceutical/Biotech manufacturing experience, Korber MES experience, Kneat platform C&Q documentation, PAT/APC/AR/VR/IIoT/IDA technologies, 21 CFR Part 11 compliance
Technologies
Emerson Delta V, Rockwell FactoryTalk, Rockwell PLCs, Aveva PI, Korber MES, Kneat platform
Responsibilities
Own delivery of IS/Automation project portfolio, 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, Elicit and analyze business customer needs into functional design
Seniority
Principal, hands-on IC with strategic oversight
