Sr. Mfg Systems Engineer- Automation

Sr Mfg Systems Engineer – Automation

As a member of the Amgen Manufacturing & Clinical Supplies – Facilities & Engineering (MCS‑F&E) Automation team, you will support Clinical & Commercial Drug Product Plant Automation.

• Develop and maintain process control automation solutions using Rockwell and Siemens PLC, HMI, and SCADA.
• Support functional area projects focused on improving process equipment, utilities, facilities, and sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facilities.
• Lead or support technical root cause analysis, incident investigations, and problem resolution related to process control issues within plant operations.
• Support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing system configuration changes, and supporting engineering and process qualification runs as applicable.
• Provide Continuous Improvement initiatives, including safety, reliability, efficiency, and environmental sustainability improvements to meet Amgen’s goals.
• Maintain data integrity assessments in accordance with current Amgen and industry standards.
• Collaborate with the Amgen Drug Product Plant network to improve automation design for ATO Drug Product Plant operations.
• Day‑to‑day operational support, including 24/7 onsite/on‑call duties, troubleshooting support to manufacturing operations, automation system administration, operating system and hot‑fix assessments and rollout, daily manufacturing and engineering work‑center meetings, preventative and corrective maintenance, spare parts management, and true root‑cause investigations and resolutions in collaboration with equipment vendors.
• Lead business process improvements, including development and maintenance of departmental standard operating procedures (SOPs).

Basic Qualifications:

• Doctorate degree.
• Master’s degree with 3 years of manufacturing automation engineering experience.
• Bachelor’s degree with 5 years of manufacturing automation engineering experience.
• Associate degree with 10 years of manufacturing automation engineering experience.
• High school diploma/GED with 12 years of manufacturing automation engineering experience.

Preferred Qualifications:

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, or Biotechnology.
• Extensive background in programming, design, installation, and lifecycle management of manufacturing process controls, automation, and field instrumentation.
• Hands‑on experience developing process control strategies for new product introduction.
• Direct knowledge of automation design and experience in process control engineering within GMP biopharmaceutical production facilities.
• Demonstrated experience with continuous improvements that enhanced safety, reliability, and efficiency (e.g., reduced cycle times and plant utilities usage).
• Experience in capital project lifecycle management, including conceptual design, scope and cost estimation, detailed design, engineering, validation documentation, and project leadership.
• Strong leadership, technical writing, and communication skills.
• Ability to perform independently, self‑motivated, organized, able to multitask in project environments, and skilled in facilitation and teamwork.
• 4+ years of combined experience with Rockwell Automation SCADA and PLC, Siemens SCADA and PLC, iFix SCADA, electronic batch reporting system design and implementation, process control network design with segregation, virtual infrastructure design and implementation, system integration using OPC and Ethernet/IP, ODBC and RDBMS interfaces, and compliance with 21 CFR Part
  11, ASTM
  2500, S88, S95, and GAMP.
• Knowledge of custom‑off‑the‑shelf Drug Product unit operations such as lyophilizer, vial filler, vial washer, capper, depyrogenation oven, and tray loader.

The annual base salary range for this opportunity in the U.S. is $ to $.

• Comprehensive employee benefits package, including a retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending…