Principal Test Methods Engineer - FPT CORE
Principal Test Methods Engineer - FPT CORE
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.
Reporting to the CORE test methods team in Final Product Technology (FPT), the Principal Methods Engineer (PME), will lead a group of combination product test methods development engineers and a mechanical / data automation team. The test methods and test automation developed in this team will support testing for design control characterization / verification. These test methods will go on to serve as manufacturing process controls throughout the Amgen Global Manufacturing network. The position will require roughly 20% travel (post Covid-19).
The successful PME candidate will have demonstrated multi-disciplinary and multi-functional product leadership experience. The PME will be responsible for supervising and coaching engineers though technical challenges in developing, characterizing, qualifying, validating and transferring methods that measure the electrical, mechanical and physical properties of primary containers, packaging components, mechanical drug delivery pens, and electromechanical autoinjectors. The PME will launch medium to long range projects to improve the test method process. The PME will also bring a background of manufacturing automation experience to help build an automation team that includes mechanical automation (mechatronics), and CFR Part 11 compliant data automation (CFR Part 11). Group members within the functional area look up to this position as a scientific/technical expert who can provide guidance on associated issues as needed. The position needs demonstrated supervisory skills.
PME Responsibilities include supervising a team that:
- Owns and maintains a compliant business processes for development, validation, transfer and lifecycle management of electrical, mechanical and physical test methods for manufacturing process control.
- Manages the method lifecycle of released methods, including trending of methods metrics, pareto and root causing of methods issues at the manufacturing sites. Manages the CAPAs and Change Controls to fix them.
- Transfers validated methods to incoming inspection, process monitoring, and product release labs across the Amgen Global Manufacturing network.
- Ensures test methods validation, transfer, and lifecycle management documentation can withstand audits and pass regulatory agency scrutiny.
- Ensures that automated test equipment development, programming, and validation can withstand audits and pass regulatory agency scrutiny.
- Rapidly Design, develop and qualify and innovate automated inspection equipment for Amgen primary containers and devices to meet new and unique product requirements.
- Owns procedures for the automation of test data creation, storage, retention, and audit in accordance with Title 21 CFR Part 11 Compliance and 21 CFR 820 design control requirements
- Facilitates communication with Amgen sites and vendors to establish user requirements for design and procurement of test automation equipment for the commercialization of drug products and devices.
- Owns and manages the process for creation and use of working Reference Standards for use within Amgen's engineering and manufacturing groups
- Advises others on methods to resolve measurement problems, current with information government and industrial standardization committees and professional societies
- Manage projects, personnel, and laboratory through development of innovative solutions based on insightful interpretation and analysis of the problem statement or investigation
Two years of technical managerial experience directly managing people and/or leading cross functional technical teams, projects, budgets, and products.
Doctorate degree and 4 years of engineering experience
Master's degree and 6 years of engineering experience
Bachelor's degree and 8 years of engineering experience
- 8+ years of experience in the testing industry with 3+ years of test development, test equipment / test method validation, and manufacturing support of test methods.
- 3+ years' experience in leading teams of lean a lean, high performing multi-disciplinary and multi-functional technical staff.
- Demonstrated competency in PLC coding and machine automation toward the Design, develop and qualification of innovate automated inspection equipment
- Ability to communicate technical material to executive management teams in a clear and concise manner, in a manner understood by management, for the purposes of procuring project authorization.
- Experience translating the needs of cross functional groups (manufacturing, quality, marketing, regulatory, legal, supply chain) into actionable ideas and tasks for engineering and management teams.
- Experience participating and testifying in real regulatory agency audits regarding testing subject matter.
- Demonstrated competencies in automation of test data creation, storage, retention, and audit in accordance with Title 21 CFR Part 11 Compliance and 21 CFR 820 design control requirements
- Excellent problem solving, trouble shooting, and communication skills. Ability to participate in global cross-functional teams and work effectively in a highly matrixed team environment with rapidly evolving challenges
- Demonstrated competencies skills and proven track record of leading cross-functional projects, ability to coach junior engineers, strong team work, excellent interpersonal and communication skills
- Solid Works engineering drawing, statistical study design, DOE, and DFM tool sets (Six sigma is highly desired).
- Experience with MS Office Suite, MS SharePoint, MS Project, Minitab/JMP, SolidWorks, LabView, and PLC controller software.
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.