Engineer – Combination Product Development, Prefilled Syringe (PFS) Platform

Career Category

Engineering

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Engineer – Combination Product Development, Prefilled Syringe (PFS) Platform

What you will do

Let’s do this. Let’s change the world. In this vital role you will be the Combination Product Development Engineer contributes to the development, verification, and transfer of prefilled syringe (PFS) platform technologies used in combination products. The engineer plans and performs engineering activities, evaluates data, prepares clear technical documentation, and coordinates with cross-functional partners. Depending on project assignment, the engineer may lead technical teams or workstreams supporting product development, platform development, and life-cycle management. The role supports reusable platform approaches that help product teams apply established device and packaging knowledge efficiently while meeting user, product, quality, and regulatory needs.

Key Responsibilities

· Lead assigned cross-functional technical teams or workstreams for product development, platform development, and life-cycle management initiatives; align contributors on scope, technical deliverables, decisions, and milestones.

· Develop and maintain technical work plans, schedules, dependencies, risks, and action tracking; communicate status and escalate issues that could affect scope, quality, or milestones.

· Contribute to PFS platform development and life-cycle management activities, including design inputs, design outputs, verification, characterization, aging, and design transfer.

· Plan and execute engineering tests for devices, primary containers, and packaging using approved protocols, procedures, and sampling approaches; document results and escalate unexpected outcomes.

· Draft and revise protocols, reports, requirements, risk assessments, technical rationales, and other design-control records in applicable document and laboratory systems.

· Analyze test data and technical information, identify trends or gaps, and communicate conclusions, limitations, and recommended follow-up to the project team.

· Coordinate assigned work with partners in human factors, risk management, primary container, packaging, device, process, quality, manufacturing, and regulatory functions.

· Support design transfer and site implementation by helping define test strategies, readiness needs, acceptance criteria, and documentation handoffs.

· Contribute to investigation of device or component issues by reviewing returned-product or test evidence, supporting root-cause activities, and documenting technical findings.

· Apply established procedures and engineering judgment to manage assigned tasks, meet commitments, maintain traceability, and raise schedule, quality, or technical risks promptly.

· Support continuous improvement of platform methods, test practices, and reusable technical data packages.

What we expect of you

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

Basic Qualifications:

Master’s degree
OR
Bachelor’s degree and 2 years ofEngineeringexperience
OR
Associate’s degree and 6 years of Engineering experience
OR
High school diploma / GED and 8 years of Engineering experience

Preferred Qualifications:

· Experience with prefilled syringes, injection devices, combination products, medical devices, or pharmaceutical packaging.

· Experience developing or executing test protocols and reports, including functional, dimensional, performance, aging, or packaging evaluations.

· Familiarity with design controls, risk management, requirements traceability, design verification, and design transfer.

· Experience using electronic document management, laboratory notebook, requirements, or project tracking systems.

· Working knowledge of statistical sampling concepts and data analysis tools.

· Demonstrated ability to communicate complex technical information clearly in writing and verbally to technical and nontechnical audiences, facilitate discussions, and build alignment.

…