Mfg Technologies Sr Mgr - Holly Springs, NC

Manufacturing Technologies Senior Manager

Let's do this. Let's change the world. In this vital role, you will manage a defined set of Manufacturing Execution Systems (MES) objects, such as GMBRs (electronic batch records) and equipment management objects (ESPs, state diagrams), that are utilized across all applicable manufacturing sites.

Specific responsibilities include but are not limited to:

• Collaborate, communicate and be accountable for leading forums with multi-functional areas and make the appropriate decisions for the best interest of Amgen.
• May include ownership of global MES SOPs in addition of provide input and review of related global training materials.
• Strategize with Technology team on application roadmap and accommodating new offered functionality.
• Own system related controlled documents such as data integrity assessment report, operational SOPs, and training content.
• Lead and approve validation documents and records such as validation plan, OQ protocol, configuration specifications, requirements specs, validation summary (backup) report, test scripts, test sets, and test runs mostly for MES but also some for ERP.