Join Amgen's Mission of Serving Patients as a Manufacturing Systems Engineer: Automation. Be part of Amgen's newest and most advanced drug substance manufacturing plant and work with a group of automation engineers to build and maintain various automation systems and platforms that support the GMP Drug Substance Plant Operations.
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, and to develop solutions using Amgen standard automation platform for process automation systems.
- 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
- Equal Opportunity employer
- Reasonable accommodation for individuals with disabilities
