Principal Mfg 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 responsible for architecting, integrating, and deploying advanced MES solutions, with a focus on PAS|X MES platforms, seamless SAP ERP and Level 2 automation system interfaces, and leveraging the latest in cloud and digital technologies.

As a member of Amgen’s Digital, Technology & Innovation organization, you will collaborate with global teams of engineers, automation specialists, IT professionals, and operations leadership to deliver robust, scalable, and compliant MES solutions. Your leadership will help drive the transformation of Amgen’s manufacturing network, ensuring operational excellence, compliance, and agility for future growth.

Roles & Responsibilities

• Lead end-to-end design, configuration, and implementation of Amgen’s NextGen MES, with a focus on PAS|X platform technical deployments.

• Drive system modernization and digital transformation by leveraging state-of-the-art technologies and integrating MES with enterprise systems (SAP, Level 2 automation, data historians, and cloud platforms).

• Serve as the technical authority and SME for PAS|X MES implementations, including requirements gathering, solution architecture, interface design, and system validation.

• Develop and maintain strong partnerships with Operations, Quality, Automation, IT, and global business collaborators to ensure MES solutions align with strategic goals and user needs.

• Oversee and manage multi-functional project teams and external partners through all project phases—design, build, test, deployment, and hypercare—ensuring delivery commitments are met.

• Champion and implement best-in-class standards for system integration, data integrity, cybersecurity, and regulatory compliance (e.g., GxP, CFR Part 11).

• Define and drive technology strategies for MES system enhancements, scalability, and cloud readiness, supporting Amgen’s digital transformation journey.

• Develop and deliver clear documentation, including functional/technical specifications, validation protocols, and training materials.

• Mentor and provide technical guidance to junior engineers and team members, fostering a culture of innovation, collaboration, and continuous improvement.

• Support change management strategies to ensure successful system adoption across global manufacturing sites.

• Serve as the partner concern point for critical MES technical challenges, incident response, and root cause analysis.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree / Master's degree / Bachelor's degree and 12 to 17 years Engineering, Computer Science, Information Systems, or a related field.

• Minimum 5+ years hands-on experience implementing and supporting PAS|X MES in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.

• Extensive technical expertise in MES solution design, configuration, and integration with SAP (PP, QM, MM modules), and Level 2 automation systems (e.g., PLCs, SCADA, DCS, OPC).

• Proven track record of leading complex, multi-site MES projects from concept through validation and go-live.

• In-depth knowledge of software development life cycle (SDLC), GxP regulations, and CSV/validation best practices.

• Experience with IT/OT cybersecurity, data integrity, and cloud-based MES architectures is highly desirable.

• Strong skills in technical documentation, collaborator engagement, and multi-functional communication.

Preferred Qualifications

• Expertise with PAS|X MES advanced modules (eBR, Equipment Management, Weigh & Dispense, Master Batch Record configuration).

• Experience integrating MES with SAP S/4HANA and/or advanced automation/data platforms.

• Familiarity with ISA-95 standards, data lakes, and supporting digital manufacturing initiatives (e.g., IIoT, AI/ML for manufacturing data).

• Experience working across global, matrixed teams and/or as a technical leader for external vendors/partners.

• Professional certifications in MES, SAP, or project management are a plus.

• Experience with containers / Kubernetes

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.