The Senior Engineer position reports into Container Science and Engineering
under Device and Final Product Technology in Thousand Oaks. This position requires the application of diverse and advanced engineering principles (mechanical and materials science), as well as excellent project management and communication skills.
Location: Thousand Oaks (CA) or Munich (Germany)
The position requires travels to international locations assisting our primary component suppliers during development, manufacturing and continuous improvement programs. Approximately 20% travel is expected.
This role will:
- Lead technical coordination with key primary component suppliers
- Determine User Requirement Specifications of primary container closure systems for new and existing Amgen products
- Provide hands-on technical leadership on primary component issues related to customer complaints, aseptic filling, lyophilization and inspection operations for the manufacture of commercial biopharmaceuticals
- Support development of characterization methods for mechanical and physical properties of primary components
- Support integration of primary containers into new and existing devices
- Support on-going NC/CAPAs and Change Control
- Collaborate extensively with internal and external project teams, i.e.
manufacturing, vendors, quality, regulatory, etc.
This role will leverage knowledge of aseptic fill finish operations, glass container
formation processes, molding of plastics/elastomers, thermal and stress analysis.
Excellent project management skills and the ability to coordinate and
communicate across different functions and sites are mandatory in order to successfully complete projects.Basic Qualifications
Doctorate Degree OR Master's Degree & 3 years of Engineering experience OR Bachelor's Degree & 5 years of Engineering experience OR Associate's degree & 10 years of Engineering experience OR High school diploma/GED & 12 years of Engineering experience.Preferred Qualifications
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.
Join Us 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.
- 2+ years of experience in project management including the ability to manage multiple projects, strategically prioritize activities and leading cross functional teams within Operations/Manufacturing
- Strong team work, excellent interpersonal and communication skills
- Direct experience with the manufacturing process (tubing, molding, extrusion, etc) of primary container systems for biopharmaceuticals, including but not limited to syringes, vials, cartridges, closures etc.
- Highly technical background and experience in the chemical/physical nature and engineering aspects of biopharmaceutical primary packaging components.
- Thorough understanding of primary package components, regulatory issues, sterile manufacturing, and hands-on experience with component testing.
- Highly technical background on biopharmaceutical product interactions with primary packaging components (leachable, extractable, lamellae, etc).
- Experience with primary component forensics analytical equipment (Keyence, X-Ray equipment, General and Electron Microscopy, etc).
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.