Engineer, Quality Engineering

"Responsibilities

• 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 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 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 (e.g., production operator, mechanics, process engineers).
• 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.
• Maintain integrated timelines capturing appropriate 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.
• Drive cross‑functional communication and integration of information to optimize decision making, issue resolution and change management throughout the project lifecycle.
• Use 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 and develop mitigation options to resolve or escalate efficiently.
• Integrate partner/vendor timelines with Amgen timelines as appropriate.

• Basic Qualifications:
• Master’s degree OR Bachelor’s degree and 2 years of engineering/scientific experience OR Associate’s degree and 6 years of engineering/scientific experience OR High school diploma / GED and 8 years of engineering/scientific experience.
• Preferred Qualifications:
• 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).

• Hourly compensation with an expected annualized salary range of $xxx,xxx.
  00 to $xxx,xxx.
  00 (U.S., excluding Puerto Rico).
• Participate in Amgen’s Total Rewards Plan, including mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory…