Engineer, Quality Engineering

Introduction

Join Amgen’s mission of serving patients. At Amgen, if you feel 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 have helped pioneer the world of biotech in our 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.

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.

• Masters degree
• Bachelors degree and 2 years of Engineering experience
• Associate degree and 6 years of Engineering experience
• High school diploma / GED and 8 years of Engineering experience

• Bachelors degree in Chemical Engineering, Mechanical Engineering, or Bioengineering
• Direct experience with regulated environments (e.g., FDA, cGMP, OSHA, EPA)
• Subject‑matter expert 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 fill‑finish equipment (e.g., filler machine, isolator, de‑pyro tunnel vial washer)
• 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 fill‑finish biopharmaceutical production, including process equipment and facilities design, procurement, construction, startup, and validation
• Displays independence, strong self‑motivation, and organization, with the ability to manage multiple priorities in a project‑based environment; effective in communication, facilitation, and collaboration
• Strong team‑oriented mindset and actively contributes to a collaborative culture that supports effective decision‑making
• Applies a continuous‑improvement mindset in daily activities and promotes a strong commitment to safety in all aspects of work
• Ability to apply sophisticated and diverse engineering principles to design and implement major system modifications, new equipment, processes, and capital projects; develops technical solutions to sophisticated problems using resourcefulness and creativity
• Develops contingency plans for potential obstacles or setbacks
• Demonstrates interest in continuous learning opportunities around new tools, techniques, and configurations to enhance analytical abilities
• Strong leadership, technical writing, and communication/presentation skills are required
• Required flexibility to support 24/7 operations, including scheduled weekend shifts, after‑hours coverage, and on‑call rotation

• 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 under 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…