Senior Manufacturing Systems Engineer: Automation Saturday Shift

Amgen is building its newest and most advanced drug substance manufacturing plant – the FleX Batch facility. This plant will combine the latest disposable technologies with traditional stainless steel equipment to provide maximum flexibility, industry‑4.0 capabilities, and sustainability innovations that support Amgen’s goal of becoming carbon neutral by 2027.

The Senior Manufacturing Systems Engineer will provide automation technical leadership to a team of automation engineers responsible for building and maintaining automation systems that support GMP Drug Substance Plant operations.

The schedule for this position will be: 4 days × 10‑hour shift:
Wednesday through Saturday.

In this vital role, you will work hand in hand with the Facilities & Engineering Automation team to deliver robust process automation systems for the new plant. This includes complex system automation initiatives that require solid understanding of automation platforms, integration among different platforms, analytical problem‑solving techniques, project management, lifecycle management, and operational excellence.

• Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).
• Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.
• Collaborate with business partners to understand how automation can improve workflow and productivity, and synthesize requirements from clients, customers or end‑users to develop the best automation solutions.
• Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current Amgen and industry standards.
• Build the business processes to support the project scope in alignment with project timelines. Develop detailed specifications and engineering policies and procedures that affect multiple organizational units.
• 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.
• Lead and support functional area projects focused on improving process equipment, utilities, facilities, and large capital projects to integrate new drug substance manufacturing technologies into the facility.
• Lead and support technical root cause analysis, incident investigations, and troubleshooting on process control issues related to plant operations.
• Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.
• Manage day‑to‑day operational support, including 24×7 onsite/on‑call support, troubleshooting for plant and manufacturing operations, process and utility automation systems, preventive and corrective maintenance, system administration, and automation system spare parts management.
• Prepare/review Standard Operating Procedures (SOP) and cGMP documents.
• Be constantly curious and feed your passion and interests in groundbreaking technology. Use your time to look for new and innovative ways to do business differently, better, and more cost effectively.

• High School Diploma / GED and 10 years of engineering experience; OR
• Associate’s Degree and 8 years of engineering experience; OR
• Bachelor’s Degree and 4 years of engineering experience; OR
• Master’s Degree and 2 years of engineering experience; OR
• Doctorate Degree.

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or a related field.
• Direct knowledge of automation system design and experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation, such as media, harvest, bioreactors, solution prep, single‑use…