Senior Manufacturing Systems Engineer - Automation

Career Category

Job Description

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.

Senior Manufacturing Systems Engineer - Automation

What you will do

Let’s do this! Let’s change the world!

In this role as a member of the Amgen Manufacturing & Clinical Supplies – Facilities & Engineering (MCS-F&E) Automation team you will support Clinical & Commercial Drug Product Plant Automation. This includes sophisticated and complicated system automation initiatives that require proven understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, critical thinking, project management, lifecycle management and Operational Excellence.

Responsibilities:

• Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).

• Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility.

• Support of capital projects. This role involves the application of advanced automation engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred. Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations.

• Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.

• Development of detailed specification, engineering documents, SOP and operating standards.

• Ownership and administration of process control automation in a GMP regulated manufacturing setting. Engage in, and process change control requests per established SOP and processes.

• Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems.

• Design and testing of automation based process equipment.

• Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.

• Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.

• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations

What we expect of you

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

Basic Qualifications:

• High school diploma / GED and 10 years of Manufacturing Automation Engineering experience OR

• Associate’s degree and 8 years of Manufacturing Automation Engineering experience OR

• Bachelor’s degree and 4 years of Manufacturing Automation Engineering experience OR

• Master’s degree and 2 years of Manufacturing Automation Engineering experience OR

• Doctorate degree

Preferred Qualifications:

• B.S or M.S. in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or Biotech Engineering.

• Strong control system automation background focused specifically in design, installation, programming and validation of automated processes are essential.