Manufacturing Systems Engineer

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Manufacturing Systems Engineer Manufacturing Operations Technology

What you will do

Lets do this. Lets change the world. In this vital role, you will be part of our Clinical and Commercial Manufacturing Operations Technology team, driving the operation, refinement, and integration of cutting-edge manufacturing applications. This role is an excellent opportunity to gain an understanding of Amgens key manufacturing systems, working with various MCS (Manufacturing and Clinical Supply) business partners to ensure products to patients by managing and supporting key computerized systems such as MES (Manufacturing Execution System), Clinical Label Printing and Packaging, PI Data Historian, Instrument Data Acquisition (IDA) and other integrated systems.

As a member of our team, you'll be the driving force behind our mission to deliver high-quality products efficiently and effectively. In addition to supporting key manufacturing operations, you will work closely on initiatives at the ATO site that enable automated data collection, support manufacturing processes with compliance and data integrity. This includes ensuring integration of instrument data, supporting standardized MES processes and protocols, and collaborating with site teams for reliable system and data collection.

Your efforts will be important in support of optimization of manufacturing systems and being an advocate for cyber resilience.

You'll collaborate closely with cross-functional teams that include Manufacturing, Supply Chain, Quality, MCS Engineering, and MES/IDA Global Teams to support optimized implementation of MES, PI Historian Systems, while helping reliable and compliant system reliability with supporting validation, system upgrades, and continuous improvements.

The role will be part of the Site Operations Technology team which is responsible for delivering systems in support of Clinical and Commercial Manufacturing, working in a client facing ATO site- focused approach.

• Support Key TCT (Trusted Core Technology) Manufacturing Systems, including operational and continuous improvements for the ATO site. This includes taking on or supporting an IT application owner role on GMP computerized systems.
• Support the site in inspection readiness, including partnering with various SMEs and IT application owners to update playbooks and representing the team in monthly computerized system forums.
• Support key system integrations, both existing and new, to streamline manufacturing operations.
• Support city plan technology and applications utilizing Artificial Intelligence (AI).
• Provide flexibility with on-call support, assisting in after-hours escalations and troubleshooting for Operations Technology application issues. The ATO site has 24x7 manufacturing operations; therefore, system changes, patching, and support in after-hours scenarios will be required.
• Support major incident and problem investigations, including root cause analysis, deviation investigations, corrective actions, and 5-why analysis.
• Ensure quality and compliance by maintaining and updating inspection readiness for critical applications, including inspection playbooks, periodic assessments for data integrity, security, and system compliance, and Software Development Lifecycle (SDLC) validation and testing.
• Support site-based projects by participating in small project teams, ensuring requirements are documented, assisting in technology assessments, and supporting adherence to long-term city planning standards.
• Support regulatory inspections by assisting with the generation of IRF documents and audit preparation activities with the ATO Site Technology team.
• Support initiatives to introduce Industry 4.0 technologies to increase manufacturing efficiency and capacity.
• Assist in CMDB (Configuration Management) updates and system health, supporting service owners and managers to ensure up-to-date information is captured.
• Support the…