Primary Container Engineer, CPO MSAT

4 weeks ago


Thousand Oaks, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Primary Container Engineer, CPO MSAT

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will ue basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution.

Responsibilities:

  • Assist with project definition by performing engineering studies and assessment for drug delivery systems.

  • Perform field evaluations of existing systems and provide engineering design recommendations.

  • Design and development of primary container systems.

  • Design and development of physical test methods with respect to container and combination product integration of drug delivery systems

  • Capable of machine design from initial conception through fabrication and into implementation.

  • Provide detailed data analysis to enable senior staff to make informed decisions.

  • Assist with project definition by performing engineering studies/assessments for device and container characterization/qualification in a GMP environment.

  • Investigate and develop new processes required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).

  • Implement projects per CPO MSAT and company procedures to ensure projects are completed on schedule and within established budget.

  • Qualify new primary container platforms

  • Update User Requirement Specifications of primary container closure systems for new and existing Amgen products

  • Provide hands-on technical support for primary component issues related to customer complaints, aseptic filling, lyophilization and inspection operations for the manufacture of commercial biopharmaceuticals

Win

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:

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:

  • Masters degree in Mechanical/Biomedical Engineering, biology, or chemistry

  • Strong team work, interpersonal and communication skills

  • ≥ 2 years of experience in the biotechnology/pharmaceutical industry

  • ≥ 2 years of experience in equipment, method, and mechanical design

  • Strong mechanical engineering and material science knowledge

  • Previous intern experience is a plus.

  • Experience with theoretical physics based modeling

  • Proficiency in Solidworks

  • Experience with combination products and regulatory requirements

  • Strong oral and written communication skills

  • Experience with computer programming in Matlab

  • Strong technical writing skills

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

  • 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 and bi-annual company-wide shutdowns

  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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.

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.



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