Principal Engineer - Physical Methods (CORE- Thousand Oaks)

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Principal Engineer Physical Methods (CORE- Thousand Oaks)

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new sciences 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 spectacularly improve peoples lives.

Collaborating with the Sr. Manager of Physical Methods Development, CORE, the successful candidate for this position will provide integrated management of the Combination Products Organization CORE mechanical laboratories. These key laboratories serve CORE in the development of container closure integrity methods, physical methods, characterization studies, and design verification work for combination products.

The principal engineer will operate in a highly matrixed environment to collaborate effectively with multi-functional teams. The principal engineer is responsible to critically analyze department requirements, ensure laboratories maintain accurate state of qualification, calibration and preparedness for inspections related to safety, compliance and procedures. The principal engineer must also clearly communicate and elevate technical or strategic issues to team members and management as needed, and make robust recommendations and/or decisions to guide successful execution of container closure integrity and mechanical testing for primary containers, device and packaging test methods. Group members within the functional area look up to this position as a scientific/technical expert who can provide mentorship on associated issues as needed. Demonstrated supervisory skills are required.

Responsibilities include leading a team to:

• Own and maintain business processes for development, qualification, validation and transfer of container closure integrity and physical test methods for product verification of new products, and transfer of validated methods to Amgen supply chain, Quality, or manufacturing labs at all Amgen sites. The principal engineer must ensure documentation can withstand an audit and pass agency scrutiny.
• Develop and own Standard Operating Procedures for data creation, storage, retention, and audit in accordance with Title 21 CFR Part 11 Compliance for all lab testing and associated 21CFR 820 requirements for device development.
• Establish a comparability process for testing between Amgen sites and between Amgen raw material vendors.
• Lead multiple Amgen laboratories, qualification of a 3rd party testing laboratory and the input/approval of raw material suppliers.
• Rapidly design, develop, qualify, and innovate automated inspection/testing equipment for Amgen primary containers and devices to meet new and outstanding product requirements.
• Work with Device Technologies to advance innovative container closure methods inclusive of tracer gas methods, high voltage leak detection, and other new emerging technologies. Support input data going into Device Master Records and associated work product with clinical and commercial manufacturing for combination products, devices and final product.
• Design, develop and complete mechanical testing using phase appropriate controls for the development and qualification of primary container platforms and medical devices to develop specifications.
• Facilitate communication with Amgen sites and vendors to establish user requirements for the characterization of primary packaging components used in the commercialization of drug products and devices
• Work closely with facilities, maintenance, instrumentation, and electrical systems to ensure laboratory equipment is maintained in compliance with all industry, regulatory, corporate, and regulatory standards. Ensure laboratory compliance for quality audits using internal and external calibration laboratories, vendors and suppliers.
• Advise others on methods of resolving measurement problems. Keep current with information from other industry experts through participation in government and industrial standardization committees and professional societies
• Manage (projects, personnel, and laboratory) an engineering group responsible for new development of innovative solutions to sophisticated biotechnology device and packaging problems based on insightful interpretation and analysis of the problem statement or investigation
• Own and manage the process for creation and use of working Reference Standards for use within Amgens engineering and manufacturing groups
• 10-25% travel to domestic and international locations is needed to help the development partners during implementation of specific container requirements into their processes

Basic Qualification

• Doctorate degree and 2 years of engineering experience OR
• Masters degree and 6 years of engineering experience OR
• Bachelors degree and 8 years of engineering experience OR
• Associates degree and 10 years of engineering experience OR
• High school diploma / GED and 12 years of engineering experience
• AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or advising the allocation of resources

Preferred Qualifications:

• MBA Degree and Engineering or related field
• 8+ years of experience with 3+ years experience in leading a highly matrixed physical characterization metrology laboratory in a highly regulated environment
• Experience including leading a lean, hard-working technical staff for 3+ years, direct experience in optimization of equipment designs, and physical methods, statistical design (Six sigma is highly desired), geometric dimensions and tolerances, kinetic modeling, Solid Works engineering drawing, DOE, and DFM tool sets
• Formal education in project management
• Excellent problem solving, trouble shooting, and communication skills. Ability to participate in global multi-functional teams and work effectively in a highly matrixed team environment with rapidly evolving challenges
• Demonstrated competencies skills and consistent track record of leading multi-functional projects, ability to coach junior engineers, collaboration, excellent interpersonal and communication skills
• Experience with MS Office Suite, MS SharePoint, MS Project, Minitab/JMP, SolidWorks

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.