Process Development Engineer

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Process Development Engineer

Live

What you will do

Lets do this! Lets change the world!

Part of Amgens Process Development (PD) organization, Drug Product Technologies (DPT) is seeking a highly motivated Engineer to provide process development support to Amgens parenteral biologics fill-finish manufacturing plant in Thousand Oaks, CA. The candidate will play a key role in bringing a wide variety of high-quality clinical and licensed drug products to patients through demonstrated excellence in technology transfer, product and process characterization, process validation and continuous process verification. A focus on visual inspection compliance and process optimization is a major expectation within this role.

Key Responsibilities:

• Engage in the new product introduction (NPI) and ongoing manufacturing activities to enable and optimize our manual visual inspection (MVI) processes for an expanding product portfolio, including make-a-batch exercises, technical assessments, and designing and performing hands-on inspectability studies with inspectors.

• Support the establishment of robust tactical and strategic objectives related to visual inspection, with emphases on the evolving state of regulatory expectations and alignment within the Amgen global network.

• Provide PD expertise for drug product visual inspection triages and investigations, including but not limited to defect identification, maintenance of defect libraries, defect rate excursions, and forensics investigation of unknown defects.

• Support the introduction of automated visual inspection (AVI) technology into the plant.

• Generate, maintain, and optimize defect kits for training MVI operators, performing MVI studies, and developing AVI recipes.

• Author, review, and data verify technical documents for all the above responsibilities per good documentation practices.

• Provide subject matter expert guidance to regulatory submissions, responses to agency questions, and technology transfers to other Amgen plants.

• Participate in knowledge management and dissemination activities to bolster MVI and AVI knowledge across the enterprise.

Win

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:

• High school diploma / GED and 8 years of Engineering experience OR

• Associates degree and 6 years of Engineering experience OR

• Bachelors degree and 2 years of Engineering experience OR

• Masters degree

Preferred Qualifications:

• Degree in engineering, chemistry, physics, life sciences, or related field.

• Experience in the pharmaceutical or biotechnology industry, including knowledge of Quality systems and current good manufacturing practice (CGMP) regulations.

• Professional experience that includes elements of visual inspection within a manufacturing process.

• The ability to learn and act upon dynamic information at a rapid pace in a multi-functional team environment.

• Proficiency in technical problem solving, critical thinking, and the delivery of value-adding solutions with limited oversight and technical direction.

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.

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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.