Engineer - Physical Methods

Role Summary

The Engineer, in Physical Methods, develops, qualifies, validates, and transfers GMP physical test methods for combination products, devices, primary containers, and secondary packaging parts. The role involves managing multiple projects concurrently that may involve changes or new product, processes, tooling, or equipment to improve quality, reliability, and reduce cost. Phases of projects include developing combination product test methods and providing experienced support for qualification, validation, transfer, and lifecycle support of methods for manufacturing, new product introduction, training, and production support.

Responsibilities

• Develop, qualify, validate, and transfer 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 operational processes.
• Coordinate test method development and delivery with selected contractors.
• Provide experienced 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).
• Generate/author and be responsible for the Test Method documents.
• Generate procedures necessary to support department and new process equipment.
• Develop, integrate, and implement new process technology and equipment.
• Assess, manage, and implement equipment lifecycle changes.
• Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget.
• Provide experienced support for investigations as well as new process development required to improve manufacturing operations.
• 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.
• Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams).
• 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.
• Align with the requirements, responsibilities, and authority as required.
• Maintains integrated timelines collecting appropriate multi-functional details and work which are aligned with the functional and project work.
• Network internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects.
• Networks with manufacturing, quality and regulatory organizations both internal and external to Amgen.
• Drive multi-functional communication and integrate information to optimize decision making, issue resolution and change management throughout project lifecycle.
• Demonstrate excellent verbal and written communication skills are applied 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 implement solutions that resolve issues or increase efficiency.
• Integrate partner/vendor timelines with Amgen timelines as appropriate.

Qualifications

• Required: High school diploma / GED and 8 years of Engineering / Scientific experience OR Associate’s degree and 6 years of Engineering / Scientific experience OR Bachelor’s degree and 2 years of Engineering / Scientific experience OR Master’s degree.
• Preferred: MS in Mechanical Engineering, Chemical or Biomedical Engineering, or Chemistry.
• Preferred: Excellent written and verbal communication skills.
• Preferred: Ability to work in a highly matrixed team environment.
• Preferred: 2 years of experience in the biotechnology/pharmaceutical industry.
• Preferred: 2 years of experience in equipment, method, and mechanical design.
• Preferred: Technical writing experience.
• Preferred: Experience with SolidWorks (or other 3D-CAD software).
• Preferred: Experience with combination products and regulatory requirements.
• Preferred: Experience applying Minitab (or other statistical software packages).

Education

• Master’s degree
• Bachelor’s degree with 2+ years of Engineering / Scientific experience
• Associate’s degree with 6+ years of Engineering / Scientific experience
• High school diploma / GED with 8+ years of Engineering / Scientific experience