Engineer – Combination Products Operations

About the role

Amgen is seeking an Engineer to join the Combination Products Operations – Manufacturing Science and Technology team. In this role you will support the development, qualification, validation and transfer of physical GMP test methods for combination products, devices, primary containers and secondary packaging.

Key responsibilities

• Develop, qualify and validate GMP physical test methods for vials, prefilled syringes and injection devices.
• Transfer new combination product test methods and assembly requirements to manufacturing, applying Six Sigma processes and preparing documentation.
• Qualify, validate and transfer new equipment, software, systems and methods.
• Lead projects in accordance with Combination Products Operation procedures, ensuring schedule and budget compliance.
• Provide expert support for investigations and new process development to improve manufacturing operations.
• Coordinate test method development and delivery with external contractors.
• Support cost estimate development for new processes, gauges and equipment for capital request documentation.

Required profile

• Ability to manage multiple projects simultaneously.
• Experience with GMP environments and combination product manufacturing.

Required skills

• GMP test method development
• Six Sigma methodology
• Qualification and validation of equipment and processes
• Project coordination with contractors