Manufacturing Systems Engineer: Automation

Requirements

• Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).
• Collaborate with key stakeholders and end-users to understand and synthesize key process requirements.
• Provide clear documentation for delivered solutions and processes.
• Support QA partners in performing computerized systems validation in a GxP environment.
• Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards.
• Support process automation systems to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements.
• Support vendor FAT to ensure that control strategy and software code meet Amgen requirements.
• Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes.
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.
• Own and drive to completion Change Controls, CAPAs, and Deviations.
• Support technical root cause analysis, incident investigations, and troubleshooting.
• Support functional area projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility.
• Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability.
• Support day-to-day operations including rotational on-call support.
• Prepare/review Standard Operating Procedures (SOP) and cGMP documents.

Benefits

• Competitive benefits
• Comprehensive Total Rewards Plans
• Collaborative culture