Principal Engineer

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Live

What you will do

Lets do this. Lets change the world. In this vital role you will:

• Reporting to the Director - Physical Methods, the successful candidate for this position will manage (projects, personnel, and laboratory) an engineering group responsible for development of innovative solutions to complex biotechnology device and packaging problems based on insightful interpretation and analysis of the problem statement or investigation. These key activities serve in the development of physical methods, characterization studies, and design verification deliverables for the Combination Products Operations.
• The principal engineer will operate in a highly matrixed environment to collaborate effectively with cross functional teams. The principal engineer is responsible to critically analyze department requirements, ensure documentation and laboratories maintain proper 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 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 guidance on associated issues as needed. Demonstrated supervisory skills are required.

• 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 utilizing 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
• 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

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

High school diploma / GED and 12 years of engineering experience

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• 8+ years of experience with 3+ years experience in leading a highly matrixed physical characterization metrology laboratory in a highly regulated environment
• Experience including managing a lean, high performing 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 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
• Experience with MS Office Suite, MS SharePoint, MS Project, Minitab/JMP, SolidWorks

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a dynamic engineer with these qualifications:

• Own and maintain business processes for development, qualification, validation and transfer of 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.
• Rapidly design, develop, qualify, and innovate automated inspection equipment for Amgen primary containers and devices to meet new and unique product requirements.
• Work with Device Technologies to advance state of the art physical methods and other emerging technologies to characterize, evaluate, and release combination products, primary containers, and secondary packaging. The candidate is expected to support input data solutions going into Device Master Records and associated work product with clinical and commercial manufacturing for combination products, primary containers, and secondary packaging.
• Design, develop and implement 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

What you can expect of us

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.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.