Manufacturing Systems Engineer

Manufacturing Systems Engineer – Manufacturing Operations Technology

What You Will Do
- Drive the operation, refinement, and integration of manufacturing applications within the Clinical and Commercial Manufacturing Operations Technology team.
- Manage and support key computerized systems including MES (Manufacturing Execution System), Clinical Label Printing and Packaging, PI Data Historian, Instrument Data Acquisition (IDA), and other integrated systems.
- Support ATO site initiatives for automated data collection, compliance, and data integrity (including instrument data integration and standardized MES processes/protocols).
- Collaborate with cross-functional teams (Manufacturing, Supply Chain, Quality, MCS Engineering, MES/IDA Global Teams) to implement and improve MES and PI Historian systems, supporting validation, system upgrades, and continuous improvements.
- Support Key TCT (Trusted Core Technology) Manufacturing Systems, including operational and continuous improvements; may support/serve as an IT application owner for GMP computerized systems.
- Support inspection readiness (update playbooks with SMEs/IT application owners; represent team in monthly computerized system forums).
- Support system integrations (existing and new), city plan technology/applications using AI, and Industry 4.0 initiatives.
- Provide 24x7 on-call flexibility for after-hours escalations/troubleshooting; support system changes and patching.
- Lead/participate in major incident and problem investigations (root cause analysis, deviation investigations, corrective actions, 5-why).
- Maintain/update inspection readiness for critical applications (playbooks, data integrity/security/system compliance assessments, SDLC validation/testing).
- Support site-based projects (requirements documentation, technology assessments, adherence to city planning standards).
- Support regulatory inspections (generation of IRF documents and audit preparation support).
- Assist with CMDB updates and system health; support weekly ATO CAB change assessments.
- Support cyber resiliency efforts (e.g., Sentinels and ECR Network).
- Provide on-site, client-facing support at the ATO site up to five days per week.

Basic Qualifications
- Master’s degree
- OR Bachelor’s degree and 2 years of Information Systems/Manufacturing Systems Engineering experience
- OR Associate’s degree and 6 years of Information Systems/Manufacturing Systems Engineering experience
- OR High school diploma/GED and 8 years of Information Systems/Manufacturing Systems Engineering experience

Preferred Qualifications
- Proactive, resourceful self-starter who owns issues, seeks root causes, and continually learns
- Good communication skills; can share technical details, articulate issues, and propose solutions
- Strong learning agility; quickly gains proficiency in new systems/processes/technologies
- Experience with Amgen Technology Systems support and validation
- Experience with cGMP and supporting audits
- Experience with CDOCS and Application Lifecycle Management (ALM)
- Work experience in biotechnology, pharmaceutical, or healthcare organizations
- Technical writing experience (specifications, change control records, incident support)
- Experience integrating small QC systems or automation systems (plus)

Application Instructions
- Apply now via careers.amgen.com.
- No application deadline; applications accepted until a sufficient number is received or a candidate is selected.
- Sponsorship for this role is not guaranteed.