Principal Manufacturing Systems Engineer- Formulation and Filling

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Principal Manufacturing Systems Engineer- Formulation and Filling

Live

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 troubleshooting 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 Drug Product manufacturing processes.

Job Responsibilities include:

Provide technical leadership for Day-to-day operational shift support for Drug Product 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
• Siemens PLC & SCADA Platform
• GE Intellution iFiX SCADA
• Wonderware SCADA System

Day-to-day Operational Support:

• 24 x 7 Onsite/On Call: Day-to-Day Rotational Support
• Trouble shooting Support to Mfg. Operations

Be a Subject Matter Expert for Drug Product Filling lines by:

• Establishing close working relationships with the Filling Line Original Equipment Manufacturers (OEMs) to better understand the equipment and Automation system design.
• Leading advanced trouble shooting activities in partnership with the OEMs, Plant Engineering, & Maintenance teams to enhance manufacturing uptime through the highest reliability of filling lines to Manufacturing.
• Responsible for driving continuous improvement in partnership with plant engineering, maintenance, and OEMs to drive operational efficiencies for the assigned filling line.
• Responsible to maintain User requirements, Design & Engineering specifications, drawings, Data Integrity assessment, Periodic reviews & Spare parts management.
• Responsible for collaborating within the Amgen network to learn, implement, and share Continuous improvement opportunities within the Drug Product manufacturing Amgen Global network.
• Responsible for maintaining and providing support for the operations of the associated plant utilities (WFI, RO, Clean Steam, UPS power distribution, Manufacturing Information System network infrastructure) related to the assigned filling line.
• Responsible for maintaining Amgen Enterprise Cyber Resiliency compliance through quarterly OS patching of automation systems, servers & workstations.
• Executive presence & communication of 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, you are accountable for and responsible for providing the necessary support during the internal and external regulatory audits for the assigned filling lines.

As System owner, provide Amgen User requirements to OEMs/System Integrators during the development of process control applications using 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 communicate the progress to the key partners. Lead and support Capital projects. This role involves the application of automation engineering principles in the design, specification, construction, startup, commissioning, and qualification 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