Principal Manufacturing Systems Engineer (Delta-V, Rockwell)

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.

Principal Manufacturing Systems Engineer (Delta-V, Rockwell)

What you will do

Let’s do this. Let’s change the world. In this dynamic role the Principal Manufacturing Systems Engineer will ensure the success of Drug product manufacturing through an extensive understanding and solid background in engineering, configuration, programming, installation, commissioning, maintenance and trouble shooting of process controls, automation, electrical devices and field instrumentation technologies. The Principal Engineer will design, develop, and deliver innovative solutions enabling the advancement of Amgen Clinical and Commercial Drug Substance manufacturing processes.

Responsibilities include:

• Provide technical leadership for Day-to-day operational shift support for Upstream and Downstream Drug Substance manufacturing.
• Experience in change control, nonconformance, corrective & preventative actions, and Commissioning & Qualification activities.
• Experience with the following product platforms.
• Rockwell Automation Factory Talk & ControlLogix PLC Platform
• Emerson DeltaV
• Day-to-day Operational Support:
• 24 x 7 Onsite/On Call: Day to Day Rotational Support
• Trouble shooting Support to Mfg. Operations
• Be an authority for Upstream and Downstream Unit operations by
• Leading advanced trouble shooting activities in partnership with the Plant Engineering & Maintenance teams to enhance manufacturing uptime through the highest reliability of Automation systems to Manufacturing.
• Being responsible to drive continuous improvement in partnership with Plant Engineering, Maintenance, Manufacturing, Process engineering and OEMs to drive operational efficiencies.
• Responsible to maintain User requirements, Design & Engineering specifications, drawings, Data Integrity assessment, Periodic reviews & Spare parts management.
• Responsible to collaborate within the Amgen network to learn, implement and share Continuous improvement opportunities within the Drug Product manufacturing Amgen Global network.
• Responsible to maintain and provide necessary support for the associated Building Management systems and plant utilities (WFI, PUR, Clean Steam, UPS power distribution, Manufacturing Information System network infrastructure) operations.
• Responsible to maintain Amgen Enterprise Cyber Resiliency compliance through quarterly OS patching of automation systems, servers & workstations.
• Executive presence & communicate complex automation topics in the simplest business language at various partner forums in the workplace: Daily plant Work Center Team (WCT) meetings, Weekly plant performance review, F&E WCT, & MCS SLT WCT, Purposeful Presence on the Floor (PPoF)
• As System Owner, be accountable and responsible to provide the necessary support during the internal and external regulatory audits.
• As Automation System Owner, lead new product introductions or new technology introductions in collaboration with multi-functional teams by performing engineering assessments, lead implementation of automation system configuration changes, and supporting engineering & Performance qualification runs.
• As System owner, provide Amgen User requirements to OEMs/System Integrators during the development of process control applications applying Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA), and development of Batch Reports using Manufacturing Execution System (MES) platform.
• Lead & implement Continuous improvement & Department Capital projects by developing the scope, budget, schedule, resource demand, develop & present the business case, obtain the management approvals, and co