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The Engineer, in Physical Methods, is 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 parts. The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling or equipment introduction to improve quality and reliability and reduce cost. Phases of projects include: developing combination product test methods, providing key experienced support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support.
Job Responsibility:
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
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
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
Requirements:
High school diploma / GED and 8 years of Engineering / Scientific experience
Associate’s degree and 6 years of Engineering / Scientific experience
Bachelor’s degree and 2 years of Engineering / Scientific experience
Master’s degree
Nice to have:
M.S. in Mechanical Engineer, 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 SolidWorks (or other 3D-CAD software)
Experience with combination products and regulatory requirements
Experience applying Minitab (or other statistical software packages)
What we offer:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan