Principal Systems Engineer - Product Development

Do you want to help craft the future of biopharmaceutical manufacturing? Are you interested in working with a diverse product portfolio of life changing products in a dynamic working environment? Would you like to work with a highly motivated team of process science professionals to positively impact patients' lives?

Come join us!

To advance Amgen's mission to serve patients, we are hiring for the role of Principal Systems Engineer (PSE) in Final Product Development team. The Systems Engineering team guides the identification, development, commercialization and improvement of drug delivery technologies to provide efficient patient experience in administration of Amgen's therapeutic products. The PSE will report to our Director of Systems Engineering & Risk Management.

As a leader in the organization, the PSE will ensure the success of multi-functional drug delivery and combination product development efforts through their lifecycle from feasibility through commercial manufacture. The PSE will work in collaboration with commercial and research colleagues in identification of user needs from market insights. The PSE will lead creation and management of system requirements, development of system architecture, and integration of subsystems. This will require ensuring robust system architecture across the interactions, dependencies, and interfaces of subsystems.

The PSE will lead integration of the system through clinical and market entry. The successful candidate will have demonstrated strength and success in managing interactions with key partners and colleagues from across process development, operations, research and development, and global commercial organizations to ensure accurate capture of the voice of customer and business into user needs.

Role Responsibilities:

• Lead development of robust drug delivery systems and coordinated development efforts utilizing best Systems Engineering principles in combination product development cycles.
• Lead formal and ad-hoc technical and design reviews for the coordinated system
• Orchestrate system definition in conformance to global regulatory principles and best engineering methods including User Needs and System Design Inputs
• Responsible for DHF development and transparency of structure across platform, combination product, and vendor structures to ensure quality and visibility
• Owns integration of requirements, risks, and implemented mitigations through downstream design outputs.
• Drives system verification and validation strategies across platform and brand-specific presentations.
• Owns system performance & reliability targets and subsystem allocations
• Provides authorship and expert technical leadership for regulatory filings
• Responsible for mentoring, supervision, and advised professional development of more junior engineers

Basic Qualifications

Doctorate degree

OR

Master's degree and 6 years of Engineering experience

OR

Bachelor's degree and 8 years of Engineering experience

OR

Associate's degree and 10 years of Engineering experience

OR

High School diploma / GED and 12 years of Engineering experience

Preferred Qualifications:

• Prior personnel management experience
• Master's Degree or PhD in Engineering in mechanical, systems, materials, electrical, or biomedical engineering
• 10+ years of demonstrated success in medical device, drug delivery, or combination product development for clinical and commercial entry
• 5+ years of demonstrated success leading development of system architecture and design for medical device, drug delivery, or combination products from concept through market entry
• Demonstrated product design and development success through product launch in major global regulatory regions
• Successful experience managing multiple projects in a deadline driven environment
• Demonstrated strength in controlled development of user needs, market and system requirements, system and process verification and validation strategies, DOE / SPC / Risk Management methods
• Proficiency driving CTQ hierarchical decomposition (flow-down) to subsystems and components
• INCOSE certification or formal Systems Engineering training/certification
• Strong understanding of injection molding, electronics fabrication, system assembly and manufacturing processes
• Solid understanding of aseptic fill finish and controlled manufacturing environments
• Demonstrated success in platform product development with global multi-generation technology plans
• Robust knowledge of Quality Management Policies and Systems, practical experience in configuration management and change control process/requirements - CCB (change control board), CIT (change implementation team) concepts
• Proficient with Production Part Approval Process (PPAP) methodology, detailing requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software
• Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
• Familiar with the following standards: US Good Manufacturing Practices (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820); Needle-based Injection Systems (ISO 11608-1); Quality Management (ISO 13485); Risk Management (ISO 14971); EU Medical Device requirements (EU MDR 2021); Medical Electrical Equipment (EN 60601)

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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.

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.