Senior ManagerProcessEngineering - Bulk Drug Substance - Downstream

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 the fight against the world’s toughest diseases. With a 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.

In this vital role, you will oversee the engineering team, lead technical projects, and drive innovation in product design and manufacturing processes. You will solve complex engineering problems, optimize processes, and ensure the company’s engineering efforts align with strategic objectives. You will also provide leadership and guidance to the engineering team supporting 24/7 manufacturing and facility operations.

• Design, construct, start‑up, and maintain operational readiness of the new FleX Batch facility, combining single‑use technologies with traditional stainless steel equipment.
• Execute and guide the commissioning and qualification of process equipment in alignment with GMP requirements, working with global engineering during site installation for on‑time project delivery.
• Ensure all systems are installed, operate safely, and comply with environmental, health, and safety regulations.
• Perform engineering assessments for plant equipment operations, implement modifications, and support engineering runs for new product or technology introductions as required.
• Provide system ownership for downstream purification skids (chromatography, viral filtration, UF/DF) and CIP/SIP skids.
• Lead a team of Process Engineering professionals and serve as the main point of contact for the Process and Equipment engineering function.
• Establish clear expectations and priorities for staff, encouraging a culture of continuous improvement, partnership, and knowledge sharing, and providing development opportunities and feedback.
• Collaborate with key customers and support groups—including Manufacturing, Quality, Process Development, and Maintenance—to meet operational goals.
• Work with original equipment manufacturers for breakdown and planned maintenance of process equipment.
• Coordinate with integrated service providers for day‑to‑day operational activities, breakdown, and planned maintenance.
• Identify and implement engineering‑based improvements or upgrades to process equipment systems, develop business cases, and translate requirements into design specifications and validation plans.
• Develop equipment maintenance programs, ensure spare part availability, and coordinate maintenance activities to keep systems in proper working order.
• Ensure plant readiness and compliance for internal, external, and partner audits of process equipment.
• Guide the identification of performance risks and implementation of risk‑reduction strategies.
• Provide technical support to troubleshoot and resolve process and system issues as needed.
• Deliver strategic, tactical management, and leadership to maintain 24/7 daily reliability of plant operations.
• Participate in the budgeting process for Process Engineering, forecasting costs, managing expenditures, and ensuring efficient resource allocation.
• Travel – 10% domestic or international.

• High school diploma / GED and 12 years of engineering experience OR
• Associate’s degree and 10 years of engineering experience OR
• Bachelor’s degree and 8 years of engineering experience OR
• Master’s degree and 6 years of engineering experience OR
• Doctorate degree and 2 years of engineering experience

• In addition to meeting at least one of the above…