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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to spectacularly improve people’s lives.

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.

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 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 methods.

• 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.

• 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 development used in generation of capital request documentation.

• Generate procedures necessary to support department and new process equipment.

• 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).

• Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams).

• Generate/author and be responsible for 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

• 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

• Networks 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

• Drives the multi-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle

• Excellent verbal and written communication skills are applied to communicate project status and risks associated with integrated timelines to leadership

• Collaborates with other functional leaders to ensure project success, momentum and commitment

• Proactively identifies issues and/or risks and develops mitigation options to resolve or increase efficiently

• Integrates partner/vendor timelines with Amgen timelines as appropriate

The position will require approximately 10% travel to international locations assisting our development partners during implementation of container closure integrity methods into their processes.

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 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)

• Experience with machine controls (PLC, HMI) and vision systems

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.