Principal Primary Container Engineer

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.

Principal Primary Container Engineer

What you will do

Let’s do this. Let’s change the world.

In this dynamic role the principal primary container systems engineer will design, develop, and deliver innovative solutions enabling the advancement of Amgen Clinical and Commercial success of Drug product manufacturing through an extensive understanding and solid background in engineering. In addition in this role as a Senior Manager of Engineering, oversees the engineering team, leads technical projects, and drives innovation in product design and manufacturing processes. They solve complex engineering problems, optimize processes, and ensure the company's engineering efforts align with strategic objectives.

Responsibilities include:

• Provide technical leadership

• Lead the design control process and qualification of primary components

• Lead the integration of primary containers into new and existing devices

• Lead the development projects for combination products.

• Develop specifications of primary container closure systems for new and existing Amgen products and platforms

• Lead a team of primary container engineers, including selection, on-boarding, assigning training and managing according to cGMP procedures and requirements and existing Amgen products and platforms

• Support development of characterization methods for mechanical and physical properties of primary components

• Support ongoing Nonconformance/CAPA and Change Control

• Collaborate extensively with internal and external team members, i.e. manufacturing, suppliers, quality, regulatory, senior management etc.

• Drive and influence key opinion leaders by providing technical papers, presentations and attending key conferences.

• Being responsible to drive continuous improvement in partnership with platform, device and drug product teams to drive operational efficiencies.

• Responsible to maintain User requirements, Design & Engineering specifications, drawings, Data Integrity assessment, Periodic reviews & Spare

• Responsible to collaborate within the Amgen network to learn, implement and share Continuous improvement opportunities within the Drug Product manufacturing Amgen Global network.

• Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations. Responsible to develop & maintain Engineering Specifications, documents, drawings, and Standard Operational Procedures (SOP).

• Conversant with industry standards on quality and regulatory compliance requirements such as 21 CFR Part 11 (Data Integrity, User Security, System Disaster Recovery, Data Backup & Restore).

• Support a Safe working environment by aligning with all pertinent environmental health, safety & maintenance program practices, rules, and regulations.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of Engineering experience 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:

• Ph. D. in Biomedical Engineering, Chemical Engineering, or related Biological Science field with at least 5 years of experience in the Pharmaceutical/Biotechnology industry or Medical Device industry

• B.S. in Mechanical, Biomedical Engineering, Polymer Engineering or Materials Science with 10+ years of experience in the Pharmaceutical/Biotechnology industry or Medical Device industry.

• Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.

• Proven track record of leading and driving multi-functional projects

• Strong team work, excellent interpersonal and communication skills.

• Experience with the manufacturing process (glass/elastomers/polymers) for medical (aseptic) applications.

• Ability to work in a highly regulated and ever-changing industry

• Experience in forensics analytical techniques and equipment

• Ability to learn and rapidly adapt to new requirements in a fast moving environment

• An Operational Excellence approach to work product – driving rapid results.

• A passion to deliver excellent work product, develop others with an infective positive attitude!

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. 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.

careers.amgen.com

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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.