Principal Manufacturing Systems Engineer

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 the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -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 lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Principal Manufacturing Systems Engineer

What you will do

Let's do this! Let's change the world! In this vital role you will provide automation technical leadership to a group of Automation Engineers who are responsible to build and maintain various automation systems and platforms that support the GMP Drug Substance Plant Operations.

In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand with project teams and site operations teams to deliver robust automation systems to operate multiple manufacturing facilities. This includes complex and challenging system automation initiatives that require detailed understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management and Operational Excellence.

Responsibilities:

• Develop and maintain process control automation solutions applying DeltaV Distributed Control System (DCS), Human Machine Interfaces (HMI), Building Management Systems (BMS), and Supervisory Control and Data Acquisition systems (SCADA) spanning the entire S88 model.

• 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. 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 project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units.

• Build a robust talent pipeline with diverse capabilities. Partner with HR to recruit, coach, develop, motivate, and retain staff. Ensure an ongoing organizational structure capable of adapting to evolving business needs. Establish technical training, leadership training, and cross-training plans to continually develop staff and build breadth and depth in the organization. Partner with staff to establish robust long-term development plans aligned with their aspirations and build robust succession plans through awareness of site, network, and external talent.

• 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 solving problems 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.

• Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Manufacturing Automation Engineering experience OR

• Associate degree and 10 years of Manufacturing Automation Engineering experience OR

• Bachelor's degree or and 6 years of Manufacturing Automation Engineering experience OR

• Master's degree and 4 years of Manufacturing Automation Engineering experience OR

• Doctorate degree and 2 years of Manufacturing Automation Engineering experience

Preferred Qualifications:

• Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering.

• Direct knowledge of Automation design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems such as media, harvest, bioreactors, chromatography, vial filtration, and ultrafiltration/diafiltration, and integrating various OEM automation software.

• Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies.

• Experience with Emerson Delta-V DCS system, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation and ability to perform advanced troubleshooting activities with Amgen IS, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.

• 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.

• Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution.

• Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.

• Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e. g. cycle times, and reduced plant utilities usage etc. ) related to Drug Substance Plant Operations.

• The ideal individual must be a self-directed teammate ready to mentor and develop engineering staff and embrace a team-based cultur.