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

1001 Amgen Inc.; Thousand Oaks (CA); Vor Ort; USD 88.000 - 119.000; Vollzeit

Benefits dieser Stelle

Retirement and Savings Plan

Stock-based long-term incentives

Flexible time-off plans

Zusammenfassung

Amgen Inc. is seeking an Engineering professional for the Combination Product Development, Prefilled Syringe (PFS) Platform.

You will lead cross-functional teams, develop plans, and support design transfer for lifecycle management of PFS technologies. The role requires experience with prepaid syringes or similar devices, strong data analysis, and the ability to communicate complex information to technical and non-technical audiences.

Qualifikationen

• Master’s degree OR Bachelor’s with 2+ years of engineering experience OR Associate’s with 6+ years of engineering experience OR high school/GED with 8+ years engineering experience.
• Experience with prefilled syringes, injection devices, combination products, medical devices, or pharmaceutical packaging preferred.
• Familiarity with design controls, risk management, requirements traceability, design verification and design transfer.
• Experience using electronic document management, laboratory notebooks, requirements, or project tracking systems.
• Strong data analysis, statistics knowledge, and ability to communicate complex information clearly.

Aufgaben

• Lead cross-functional teams for product development, platform development, and lifecycle management.
• Develop and maintain work plans, schedules, risks, and action tracking; communicate status.
• Support design transfer and site implementation with test readiness and acceptance criteria.
• Plan and execute device testing for containers and packaging per approved protocols.
• Draft and revise design-control documents, protocols, and technical reports.
• Analyze test data, identify trends, and communicate conclusions to the project team.
• Collaborate with risk, regulatory, manufacturing, and quality teams as needed.

Kenntnisse

PFS experience

Cross-functional work

Technical communication

Ausbildung

Engineering degree variants

Tools

Electronic document management systems

Jobbeschreibung

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-d drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the worlds 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 escalation 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 escalation of 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

What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being.

Basic Qualifications

• Master’s degree OR Bachelor’s degree and 2 years of Engineering experience 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.
• Experience applying project management practices to cross-functional engineering initiatives, including defining scope, milestones, dependencies, risks, and status reporting.
• Strong interpersonal skills, including collaboration, active listening, relationship building, constructive conflict resolution, and motivating contributors without direct authority.

What you can expect of us

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible.

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Sponsorship

Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Equal Opportunity

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Salary Range

88,281.00USD -119,439.00 USD

About Amgen

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. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing 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. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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