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 dramatically improve people's lives.
The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP test methods for combination products, devices, primary container, and secondary packaging components. This individual 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 project include developing combination product test methods and providing key expert support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training and production support.
- Assure transfer of new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.
- Implement projects per FPT and company procedures to ensure projects are completed on schedule and within established budget.
- Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes.
- Provide expert support for investigations as well as new process development required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).
- 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 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).
- Supervise work of support staff during development and manufacture of test methods.
- Generate/author and own the Combination Product Test Method documents.
- During all phases of engineering activities from design, through equipment acquisition, manufacture and ongoing maintenance the following requirements should be included:
- 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
- Excellent communication (written and verbal), organizational skills and executive presence
- Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables
- 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
- Identifies and manages resources and resource requirements
- Drives the cross-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle
- Supports ad hoc decision-making meetings as required for projects
- Communicates project status and risks associated with integrated timelines to leadership
- Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.
- 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
- Acts as an advisor to FPT leadership team
The position will require the approximately 10% travel to international locations assisting our development partners during implementation of mechanical engineering methods into their processes.
Master's Degree and 3 years of Engineering experience
Bachelor's Degree and 5 years of Engineering experience
Associate's degree and 10 years of Engineering experience
High school diploma/GED and 12 years of Engineering experience.
- M.S. or Ph. D. in Mechanical, Mechatronics, Chemical or Biomedical engineering
- Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrix team environment
- 2 years experience in project management including the ability to manage multiple projects, strategically prioritize activities and leading cross functional teams within Operations/Manufacturing.
- Experience with managing technical teams, including setting priorities and leveling resources
- Technical writing experience
- Spanish language skills preferred
- Experienced with SolidWorks (or other 3D-CAD software)
- Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs,
- Experience with combination products and device regulatory requirements
- Understanding of the six sigma process, utilizing Minitab (or other statistical software packages) to solve statistical problems
- Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing
- 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.
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.