Engineer, Manufacturing Engineer

What You Will Do

In this vital role you will work in Combination Products Operation – Manufacturing Science and Technology. You will be responsible for engineering activities required for the development, qualification, validation, and transfer of physical GMP test methods for combination products, devices, primary containers, and secondary packaging components. You will work on multiple projects simultaneously, focusing on changes or new product introductions, toolings, or equipment to improve quality, reliability, and cost.

Key phases include developing test methods, providing expert support for qualification, validation, and transfer, and supporting life‑cycle activities such as training and production support.

• Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
• Work in teams to transfer new combination product test methods 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 Products Operation and company procedures to ensure projects are completed on schedule and within budget.
• Provide expert support for investigations and new process development required to improve manufacturing operations.
• Coordinate test method development and delivery with selected contractors.
• Ensure qualification parameters are met for product assembly requirements.
• Support development of cost estimates for new processes, gauges, and equipment used in generation of capital request documentation.
• Generate procedures necessary to support the 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.
• Participate in and assume responsibilities of team functions as assigned (e.g., 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.
• Comply with required responsibilities and authority.
• Maintain integrated timelines capturing cross‑functional details and deliverables aligned with functional and project goals.
• Network internally to ensure alignment, commitment to project objectives and timelines, and effective execution of projects.
• Network with manufacturing, quality, and regulatory organizations both internal and external to Amgen.
• Drive cross‑functional communication and integration of information to optimize decision making, issue resolution, and change management throughout the project lifecycle.
• Utilize excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership.
• Collaborate with other functional leaders to ensure project success, momentum, and commitment.
• Proactively identify issues and/or risks, develop mitigation options, and resolve or escalations efficiently.
• Integrate partner/vendor timelines with company timelines as appropriate.

• Masters degree.
• Bachelor's degree and 2 years of engineering/scientific experience.
• Associate's degree and 6 years of engineering/scientific experience.
• High school diploma / GED and 8 years of engineering/scientific experience.

• M.S. in Mechanical Engineering, Chemical or Biomedical Engineering, or Chemistry.
• Excellent written and verbal communication skills.
• Ability to work in a highly matrixed team environment.
• 2 years of experience in the biotechnology/pharmaceutical industry.
• 2 years of experience in equipment, method, and mechanical design.
• Technical writing experience.
• Experience with Solid Works (or other 3D‑CAD software).
• Experience with combination products and regulatory requirements.
• Experience utilizing Minitab (or other statistical software packages).

• A comprehensive employee benefits package, including a retirement and savings…