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. 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, 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.

SENIOR ENGINEER, SYSTEM OWNER COMPLIANCE

What you will do

Let’s do this. Let’s change the world. In this vital role you will partner across Facilities & Engineering, Manufacturing, Quality, Validation, Environmental Health & Safety, Supply Chain, Digital Technology & Innovation, and Capital Projects to ensure engineering activities support operational excellence while maintaining a constant state of inspection readiness.

The successful candidate will demonstrate strong engineering judgment, ownership, technical leadership, and a continuous improvement mindset while driving compliance, reliability, and exceptional customer service.

• Provide system ownership for Biopharmaceutical compliance programs. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the facility systems.  This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance execution as necessary to ensure systems are in proper working order.
• Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations.
• Ensure necessary commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as necessary.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Providing troubleshooting support to reduce production downtime.  This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Facilities Quality & Compliance
• Serve as the technical lead for Facilities Quality & Compliance programs supporting GMP manufacturing operations.
• Ensure facility systems, utilities, maintenance programs, engineering activities, and documentation remain compliant with cGMP regulations, Amgen standards, and engineering requirements.
• Maintain Facilities & Engineering in a continuous state of inspection readiness through proactive compliance monitoring and risk mitigation.
• Partner with Quality Assurance during internal audits, corporate audits, customer audits, and regulatory inspections.
• Quality Systems Ownership
• Own facility-related Deviations from initiation through closure, including investigation leadership, root cause analysis, effectiveness verification, and timely implementation of corrective actions.
• Lead structured investigations using risk-based methodologies including 5-Why, Fishbone, Kepner-Tregoe, and Human Performance principles.
• Own engineering Change Controls, ensuring appropriate impact assessments, stakeholder alignment, and compliant implementation.
• Own & Manage Deviations from initiation through timely closure, ensuring sustainable corrective and preventive actions.
• Manage CAPAs from initiation through effectiveness verification, ensuring sustainable corrective and preventive actions.
• Monitor quality metrics, identify emerging compliance trends, and proactively mitigate risks.
• Engineering & Maintenance Excellence
• Support commissioning, qualification, start