Engineer

Amgen SA; Thousand Oaks, Northern (CA, KY); Hybrid; USD 121,000 - 190,000; Full time

Benefits offered by this job

Stock benefits

Retirement plan

Medical insurance

Life & disability insurance

Annual bonus

Flexible work models

Job summary

Amgen is seeking an Engineer to transfer purification drug substance processes into manufacturing, optimize bioprocess scalability, and support tech transfers between sites. The role includes data analysis, process monitoring, and on-the-floor support for scale-up in a GMP environment.

Requires a Master’s degree in Chemical/Biochemical/Biomedical Engineering or related field and two years of engineering experience, with knowledge of JMP, SIMCA, DeltaV, and PI Vision.

Qualifications

• Master’s degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, or related field plus two years in engineering or related occupation.
• Experience with technology transfer into commercial facilities and data analysis using JMP/Microsoft Office.
• Familiarity with PPQ/Process Validation and GMP settings.

Responsibilities

• Transfer purification drug substance processes from lab to manufacturing facilities.
• Support tech transfers between partner sites via Make-a-Batch discussions.
• Provide on-the-floor technical support for scale-up and transfer of process tech.
• Perform data trending and statistical process analysis.
• Contribute to deviations, CAPAs, and change controls.

Skills

Technology transfer

Data analysis

Root cause analysis

Process troubleshooting

Cross-functional collaboration

Education

Master’s degree in Chemical Engineering or related field

Tools

JMP

Microsoft Office

SIMCA

DeltaV

PI Vision

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—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.

Engineer

Duties: Transfer purification drug substance processes and perform process improvements from the laboratory into manufacturing facilities. Facilitate fit assessments for bioprocess scalability, including process modeling and equipment selection for new processes transferred to the manufacturing plant. Support new process information transfer between partner sites by facilitating Make-a-Batch technical discussions between sending and receiving site engineers. Perform commercial tech transfers of late-stage Amgen products between and within manufacturing facilities. Provide process validation support for late-stage commercial processes. Provide on-the-floor technical support for successful scale-up and transfer of process technology, and for clinical or commercial manufacturing operations. Provide routine process monitoring and troubleshooting. Perform data trending and statistical process analysis. Provide technical contributions for process related deviations (NCs), CAPAs and change controls. Identify and support process related operational excellence opportunities. Represent process development and collaborate with other functions such as Manufacturing, Quality, and Regulatory. May telecommute.

Requirements: Master’s degree (or foreign equivalent) in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, or a related field and two years of experience in the offered position or an engineering- related occupation. Position requires two years of experience in the following:

• 1. Technology transfer into commercial facilities;
• 2. Software tools including JMP and Microsoft Office Suite for data analysis and visualization;
• 3. Process monitoring using tools including SIMCA, Delta V and PI Vision;
• 4. Process performance qualification (PPQ) and process validation;
• 5. Chromatography systems, TFF and Final Fill operations in stainless-steel systems;
• 6. Develop technical protocols for experimentation in GMP setting; and 7. Root cause analysis investigations.

Job type: Full Time position. The annual salary range for this position in the U.S. is $120,869.00 - $189,864.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit https://careers.amgen.com/life-at-amgen/benefits/

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

careers.amgen.com

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.

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.