Engineer - Physical Methods

Career Category Operations 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

Let’s do this. Let’s change the world. In this vital role you will be responsible for engineering activities required for the development, qualification, validation, transfer and life cycle management of physical GMP test methods for combination products, devices, primary containers, and secondary packaging components. The Engineer shall have the ability to work on multiple projects at the same time. The work involves design and development of test methods for measuring physical attributed like dimension, force, time, …, and/or for qualitative inspection of components (e.g., visual inspection for defect).

It includes ideation of test concept, tooling and prototyping fixtures, proof of concept, feasibility and robustness, qualification of test equipment, evaluation of method characteristics, validation and transfer of the test method. It would be for new products, processes, tooling or equipment introduction to improve quality and reliability and reduce costs.

• Develop, qualify, validate GMP physical test methods for vials, prefilled syringes, and injection devices.
• Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.
• Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
• Implement projects per Combination Product Organization (CPO) and company procedures to ensure projects are completed on schedule and within established budget.
• Provide expert support for investigations as well as new process development required to improve manufacturing operations.
• Coordinate test method development and delivery with selected contractors.
• Ensure that qualification parameters are met for product assembly requirements.
• Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
• Generate procedures necessary to support department and new process equipment.
• Provide expert training to individuals in the operation and maintenance of processes, test methods and equipment introduced to Quality Control and/or the manufacturing department (i.e. production operator, mechanics, process engineers).
• Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams).
• Generate/author and own the Test Method documents.
• Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design.
• Perform other duties as required by the Group Manager.
• Follow the requirements, responsibilities, and authority as required.
• Maintains integrated timelines…