Senior Manufacturing Systems Engineer: BAS​/QBAS

Overview

Join Amgen's mission of serving patients. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we've helped pioneer biotech in our fight against the world's toughest diseases. With a focus on Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year.

As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lie within them, you'll thrive as part of the Amgen team.

Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. The FleX Batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. It will feature best-in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and integrate sustainability innovations as part of Amgen's plan to be a carbon-neutral company by 2027.

What You Will Do

Let's do this. Let's change the world. As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations. In this role as a member of the Facilities & Engineering (F&E) Automation team you will work with the capital project team to deliver robust automation systems to operate the new plant.

This includes sophisticated and challenging automation initiatives that require understanding of various automation platforms, integration between platforms, analytical problem-solving techniques, project management, lifecycle management and Operational Excellence.

• Maintain the Building Automation System (BAS) on Siemens Desigo CC.
• 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 utility and building equipment systems automation can improve workflow and productivity. 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 current Amgen and Industry standards.
• Maintain detailed specification and engineering policies and procedures that affect multiple organizational units.
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).
• Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.
• Lead/support technical root cause analysis, incident investigations, and troubleshooting on utilities and building automation controls.
• 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.
• Handle Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, Utility systems, Utility and BAS Administration, Preventative and corrective maintenance, and Automation System spare parts management.
• Be constantly curious and feed your passion and interests in groundbreaking technology. Look for new and innovative ways to do business differently, better, and with cost efficiency.

We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications.

• High School Diploma / GED and 10 years of Engineering experience OR
• Associates Degree and 8 years of Engineering experience OR
• Bachelors Degree and 4 years of Engineering experience OR
• Masters Degree and 2 years of Engineering experience OR
• Doctorate Degree

• Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering.
• Direct knowledge of BAS design, experience in building control engineering and troubleshooting with GMP biopharmaceutical production facility and utility…