Manufacturing Systems Engineer: Automation

Role Summary

Manufacturing Systems Engineer: Automation at Amgen will work with a group of automation engineers to build and maintain automation systems that support GMP Drug Substance Plant Operations. As a member of the Facilities & Engineering Automation team, you will collaborate with the capital project team to deliver robust process automation systems to operate the new plant, leveraging Industry 4.0 capabilities and supporting sustainability initiatives.

Responsibilities

• 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 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.
• Be constantly curious and seek new and innovative ways to do business differently, better, and more cost effectively.

Qualifications

• Required: High School Diploma / GED and 8 years of Engineering experience OR Associate’s Degree and 6 years of Engineering experience OR Bachelor’s Degree and 2 years of Engineering experience OR Master’s Degree.
• Preferred: Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
• Preferred: Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software.
• Preferred: Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies.
• Preferred: Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies.
• Preferred: Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies.
• Preferred: Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95.

Skills

• Strong technical writing and communication skills.
• Self-directed team player able to work cross-functionally.
• Ability to interpret and apply regulatory requirements (GAMPs, GMPs, 21 CFR Part 11, etc.).
• Analytical problem solving and effective troubleshooting of automation systems.

Education

• High School Diploma / GED
• Associate’s Degree
• Bachelor’s Degree
• Master’s Degree