Amgen Engineer in Thousand Oaks, California
The Engineer, in Mechanical Engineering 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 components. 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 expert support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, 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 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 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 development used in generation of capital request documentation.
Generate procedures necessary to support 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 (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 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 the requirements, responsibilities, and authority as required
Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals
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 cross-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 utilized 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 escalate 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.
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.
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 utilizing 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 leverages 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.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.