About us: Amgen is a global biotechnology leader committed to discovering, developing and delivering innovative human therapeutics.
We are seeking an experienced professional to join our Dun Laoghaire site in Ireland. Our state-of-the-art aseptic drug product operations facility specializes in secondary manufacturing activities including formulation, vial/syringe filling, lyophilisation and inspection.
Job Summary
* The Sr Automation Engineer (Utilities) will be responsible for the day-to-day operation reliability and compliance of our utility and building automation systems.
This role involves system ownership lifecycle maintenance validation change control management Deviation tracking CAPA implementation technical support troubleshooting root cause analysis project integration safety regulatory compliance innovation industry 4.0 champion data analytics dashboards SQL database knowledge GAMP software development lifecycle ANSI/ISA-S88 S95 industry standards 21 CFR Part 11 Annex 11 AVEVA PI System network architecture TCP/IP Firewalls etc...