US – California – Thousand Oaks
The Senior Engineer position reports into Final Product Technologies (FPT), Commercial Advancement organization. This position requires the application of engineering principles (materials science and mechanical), as well as excellent project management and communication skills. The Senior Engineer will participate in the lifecycle management related activities for the design of commercial primary containers and drug delivery devices. This includes technical support for manufacturing operations, failure investigation, design changes, test procedures development, scale-up and global launch, supplier development, and continuous improvement. The incumbent shall have capability and competency of working with multiple project teams at the same time, as well as ability to learn and self-develop expertise in the assigned areas of technology. The position will focus on engineering assignments focused on commercial primary containers, mechanical, electro-mechanical systems, and fluid-mechanical systems. The qualified candidate will be part of a Commercial Product Engineering team that ensures successful final product design transfers and sustainability of related components.
The position is located in Thousand Oaks, CA and requires up to 10% domestic and international travel.
- Doctorate in relevant discipline AND 3 or more years of related engineering experience
- Master’s degree in Engineering AND 5 or more years of related engineering experience
- Bachelor’s degree in Engineering AND 7 or more years of related engineering experience
- Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments. Plans, leads and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
- Provide hands-on technical support for any primary containers topics as well as for aseptic filling, lyophilization and inspection operations for the manufacture of commercial biopharmaceuticals.
- Accountable for maintaining technical records within design history file associated with assigned products.
- Generate and maintain design specification, write protocol & report, generate prototype, conduct DOE/SPC for product optimization, perform design verification & validation, conduct FMEA, etc.
- Lead system level root cause investigation, coordinate design improvements with development partners, strategic planning and execution of design changes and improvements.
- Support or own Deviation, CAPA and Change Control.
- Work with scientists and engineers internally and externally to assess and improve design and manufacturing specifications.
- Individual contributor with leadership attributes to effectively represent FPT engineering within a large network/matrix organization.
- A degree in Materials Science, Bio Engineering or Mechanical Engineering
- Industry experience in Pharmaceutical/Biotechnology or Medical Device
- Background in developing and commercialization of medical devices and knowledge of aseptic fill finish operations and glass container characteristics highly desirable.
- Strong capability of scientific/engineering/laboratory analysis and ability to apply advanced problem solving skills within defined constraints.
- Capability of initiating and bringing complex projects to conclusion.
- Ability to work independently and with dynamic cross functional teams is required.
- Excellent written and verbal communication skills required.
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.
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