Principal Manufacturing Systems Engineer- Formulation and Filling

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
• 24 x 7 Onsite/On Call: Day-to-Day Rotational Support.
• Troubleshooting 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).
• Leading advanced troubleshooting activities in partnership with the OEMs, Plant Engineering, & Maintenance teams.
• Driving continuous improvement in partnership with plant engineering, maintenance, and OEMs.
• Maintaining User requirements, Design & Engineering specifications, drawings, Data Integrity assessment, Periodic reviews & Spare parts management.
• Collaborating within the Amgen network to share Continuous improvement opportunities.
• Providing support for the operations of the associated plant utilities related to the assigned filling line.
• Maintaining Amgen Enterprise Cyber Resiliency compliance through quarterly OS patching.
• Communicating automation topics in simple business language at various partner forums.
• Providing necessary support during internal and external regulatory audits.
• As System Owner, provide Amgen User requirements to OEMs/System Integrators during the development of process control applications.
• Lead & implement Continuous improvement & Department Capital projects.
• Responsible for developing & maintaining Engineering Specifications, documents, drawings, and Standard Operational Procedures (SOP).
• Conversant with industry standards on quality and regulatory compliance requirements.
• As Automation System Owner, lead new product introductions or new technology introductions.
• Support a safe working environment by aligning with environmental health, safety & maintenance program practices.

Win

What we expect of you

The Engineering professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of Engineering experience
• OR Master’s degree and 4 years of Engineering experience
• OR Bachelor’s degree and 6 years of Engineering experience
• OR Associate degree and 10 years of Engineering experience
• OR High school diploma / GED and 12 years of Engineering experience.

Preferred Qualifications:

• Master’s or Bachelor’s Degree in Electrical Engineering or a related field.
• Experienced in the process automation field within the biopharmaceutical industry.
• Experience with Drug Product unit operations such as Lyophilizer, Vial & Syringe Filler, Vial Washer, Capper, Depyrogenation oven & Tray Loader.
• Experience leading teams to perform advance troubleshooting activities.

Thrive

What you can expect of us

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package.
• A discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote work arrangements.

Apply now

for a career that defies imagination

Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process.