What You Will Do
- Manage a defined set of Manufacturing Execution Systems (MES) objects (e.g., GMBRs/electronic batch records and equipment management objects like ESPs/state diagrams) used across applicable manufacturing sites.
Specific responsibilities include but are not limited to:
- Lead cross-functional forums and make decisions in the best interest of Amgen.
- Own global MES SOPs and provide input/review of global training materials.
- Strategize with the Technology team on the application roadmap and new functionality.
- Own system-related controlled documents, including data integrity assessment reports, operational SOPs, and training content.
- Lead and approve validation documents/records for MES (and some for ERP), including validation plans, OQ protocols, configuration/requirements specifications, validation summary reports, test scripts/sets, and test runs.
Basic Qualifications:
- Doctorate + 2 years Manufacturing support experience
OR Master’s + 4 years
OR Bachelor’s + 6 years
OR Associate’s + 10 years
OR High school/GED + 12 years
Preferred Qualifications:
- Life Science and/or Engineering academic background
- Leadership managing contractors and indirect reports
- Drug Substance, Finish Drug Product (FDP), and/or Drug Product background
- MES knowledge; experience modifying batch records
- English communication skills
- Koerber PAS|X MBR design experience
- MES experience in biological manufacturing floor operations
- Regulated environment experience with cross-functional collaboration
Benefits (if eligible):
- Comprehensive employee benefits package (Retirement and Savings Plan, medical/dental/vision, life/disability)
- Discretionary annual bonus (or sales-based incentive for field sales)
- Stock-based long-term incentives
- Time-off plans
- Flexible work models (remote/hybrid where possible)
Application Instructions:
- Apply now at careers.amgen.com