Engineer, Validation 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.

Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, 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.

• Support system reliability and operational optimization efforts. Identify system performance risks (e.g., single point of failure or obsolescence) and implement risk reduction strategies. Lead and execute improvement efforts, including identifying cycle‑time reduction opportunities, efficiency gains, and yield improvement opportunities.
• Support technical investigations, root cause analysis, and equipment troubleshooting activities. Apply structured problem‑solving methodologies with guidance.
• Analyze data and assist in developing engineering solutions using data techniques and methodologies (e.g., Statistical Process Control, Six Sigma, predictive maintenance analysis).
• Support new product and technology introductions by assisting with engineering assessments, equipment modifications, and execution of engineering runs.
• Collect, organize, analyze, and present results for operational issues and engineering projects of small scope and complexity.
• Provide onsite day‑to‑day technical support for equipment and process troubleshooting.
• Apply process engineering principles to support the design, specification, installation, startup, and validation of process equipment and systems.
• Assist with project activities by performing engineering studies and assessments for process equipment systems.
• Translate user and process requirements into engineering documentation and support design development in alignment with standard engineering practices.
• Communicate effectively with supervisors, cross‑functional teams, and support staff to elevate issues and contribute to solutions.
• Support a safe working environment by aligning with all pertinent environmental health/safety practices, rules, and regulations.

• Master’s degree and 2 years of engineering experience.
• Bachelor’s degree and 4 years of engineering experience.
• Associate’s degree and 6 years of engineering experience.
• High school diploma / GED and 8 years of engineering experience.

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or Bioengineering.
• Direct experience with regulated environments (e.g., FDA, cGMP, OSHA, EPA).
• Expertise and hands‑on experience with complex manufacturing process equipment, including sophisticated troubleshooting, reliability and performance improvements, and design optimization.
• Direct experience in equipment engineering and problem solving for cleaning, centrifuges, chromatography systems, and/or filtration systems.
• Foundational knowledge of Maximo or equivalent Asset Management System for managing equipment maintenance and asset lifecycle.
• Solid understanding and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment, including corrective and preventative actions, and commissioning practices.
• Experience supporting design and startup engineering directly related to bulk biopharmaceutical production, including process equipment and facilities design, procurement, construction, startup, and validation.
• Demonstrates independence, strong self‑motivation, and organization, with the ability to manage multiple priorities in a project‑based environment; effective in communication, facilitation, and collaboration.
• Demonstrates a strong team‑oriented mindset and actively contributes to a collaborative culture…