Sr. Engineer – Primary Container Engineering

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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.

Sr. Engineer

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead the initiation, design, and execution of technical projects with a focus on the design, development, and qualification of primary container systems to enable both clinical and commercial drug product launches. Success in this position requires the application of diverse and advanced engineering and scientific principles particularly in mechanical and materials science. Strong technical expertise and effective coordination across cross-functional teams are essential to driving projects to completion. The Senior Engineer must be able to manage multiple concurrent projects in a dynamic environment and may supervise direct reports.

Responsibilities:

• Lead technical workstreams and development projects by applying diverse advanced engineering principles and effective project management practices.
• Lead the design, development, and qualification of primary container systems including ownership of design control process activities.
• Lead the creation and management of design inputs and outputs including design input requirements, specifications, user needs.
• Own and lead RCA workstreams for OOS, OOT, nonconforming, and deviation events, ensuring issues are thoroughly investigated and resolved.
• Lead engineering studies and assessments of drug delivery systems across feasibility, development, and verification/qualification phases in a GMP environment. Provide comprehensive data analysis and actionable recommendations to support informed decision-making by senior leadership.
• Lead/support the authorship and management of regulatory filings, address agency questions, and represent PCE during audits.
• Lead/support the impact assessment of new and revised standards/pharmacopeias that are related to primary container systems.
• Leading lifecycle management activities for primary containers and evaluating their impact on commercialized products.
• Ensuring quality by integrating requirements, risks, and mitigation strategies into downstream design outputs.
• Provide hands-on support for primary container-related issues, such as aseptic filling and inspection challenges during NPI and commercial manufacturing.
• Own and support various quality records, including Change Controls, Deviations, and CAPAs.
• Leading technical engagements with primary component suppliers as part of the Supplier Relationship Excellence (SRE) program.
• Support development of characterization methods for mechanical and physical properties of primary components.
• Collaborating extensively with internal and external stakeholders including manufacturing, quality, regulatory, suppliers, and senior leadership.

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 go getter with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 2 years of Engineering experience

Or

Bachelor’s degree and 4 years of Engineering experience

Or

Associate’s degree and 8 years of Engineering experience

Or

High school diploma / GED and 10 years of Engineering experience

Preferred Qualifications:

• Demonstrated ability in the biotechnology or pharmaceutical industry
• Prior involvement in combination product development teams integrating device, drug, and primary packaging
• Proven experience in testing, method development, and mechanical design
• Proficient in statistical tools and methodologies including tolerance stack-up analysis, Design of Experiments (DoE), ANOVA, and Gage R&R
• Knowledge of the operation of mechanical material testing machines, various measurements equipment, and container closure integrity instrumentation
• Demonstrated project management skills with the ability to multitask and manage multiple priorities or work effectively

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

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

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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.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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 is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.