Principal Engineer - FPT Primary Container Engineering
The Principal Engineer position reports into Primary Container Engineering
under Final Product Technologies/CORE in Thousand Oaks, CA. This position requires the application of diverse and advanced engineering and scientific principles (mechanical and materials science).
Location: Boston (US/MA)
The position travels to international locations, assisting our primary component
design and development projects, up to 30% of overall time for travel is expected.
This role will:
- Lead the process development and commercialization of gas sterilization processes of combination products
- Coordinate manufacturing site requirements to support sterilization requirements
- Lead the design control process and qualification of primary components
- Lead the integration of primary containers into new and existing devices
- Lead development projects for combination products
- Develop specifications of primary container closure systems for new and existing Amgen products
- Support the development and operational improvements with key primary component suppliers
- Support development of characterization methods for mechanical and physical properties of primary components
- Support on-going Deviation/CAPA and Change Control
- Collaborate extensively with internal and external stakeholders, i.e.
manufacturing, suppliers, quality, regulatory, senior management etc.
- Drive and influence key opinion leaders by providing technical papers, presentations and attending key conferences.
This role requires knowledge of glass forming, molding/processing of polymers and elastomers, sterilization process development, microbiology, aseptic fill/finish, thermal and stress analysis, surface treatments, particle reduction, extractables/leachables, mechanical properties and industry (supplier) best practices.
Excellent communication skills (written and verbal), project management skills, and the ability to coordinate and communicate across different functions and sites/cultures are required in order to successfully complete projects. Operational excellence experience is desirable.
Doctorate degree & 2 years of Engineering experience
OR Master's degree & 6 years of Engineering experience
OR Bachelor's degree or & 8 years of Engineering experience
M.S. or Ph. D. in Mechanical, Biomedical Engineering, Polymer Engineering or
Materials Science with 5+ years of experience in the Pharmaceutical/Biotechnology industry or Medical Device industry.
B.S. in Mechanical, Biomedical Engineering, Polymer Engineering or Materials
Science with 10+ years of experience in the Pharmaceutical/Biotechnology industry or Medical Device industry.
- Direct experience with Nitrogen Dioxide (NO2), Ethylene Oxide (EO), Radiation (E-Beam and Gamma), or Steam (Autoclave) Sterilization and Vaporized Hydrogen Peroxide (VHP) Decontamination
- Ability to develop end to end sterilization processes with respect bioburden controls (Material and process, process challenge devices, lethality testing, gas residual testing, sterilization packaging design, and process validation with reference to ISO 14937
- Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.
- Proven track record of leading and executing cross-functional projects
- Strong team work, excellent interpersonal and communication skills.
- Direct experience with the manufacturing process (glass/elastomers/polymers) for medical (aseptic) applications.
- Ability to work in a highly regulated and ever changing industry
- Experience in forensics analytical techniques and equipment
- Ability to learn and rapidly adapt to new requirements in a fast moving environment
- An Operational Excellence approach to work product - driving rapid results.
- A passion to deliver excellent work product, develop others with an infective positive attitude!
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.