Engineer - Process Development Drug Substance

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 - Process Development Drug Substance

What you will do
Let’s do this. Let’s change the world. In this vital role within the Drug Substance Process Development Cell Sciences and Engineering (CS&E) organization, you will support the introduction, performance and optimization of upstream manufacturing processes for various products. You will play a key role in troubleshooting technical issues, implementing process improvements, and contributing to product development projects. This role might include non-standard shift operations, including extended hours, weekends, and holidays. 

Specific Responsibilities include but are not limited to: 

• Support manufacturing and quality systems, including non-conformances, process validation, monitoring, procedures, training, and new product introductions.
• Provide remote or on-the-floor technical support for troubleshooting and process improvements for commercial manufacturing campaigns.
• Apply engineering principles to design and implement system modifications.
• Evaluate, select, and apply standard engineering techniques and procedures under general supervision.
• Monitor manufacturing performance indicators, identify trends, and drive problem resolution.
• Collaborate with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to develop system modifications and process improvements.
• Collaborate with Drug Substance Team Leads on Regulatory deliverables for various products.
• Collaborate with departmental safety, compliance, development and integration activities.

What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Engineer - Process Development Drug Substance professional we seek is an individual contributor with these qualifications.

Basic Qualifications:
Master’s degree in Engineering
OR
Bachelor’s degree in Engineering and 2 years of engineering and/or manufacturing support experience

Preferred Qualifications:

• Degree in Chemical or Biochemical Engineering.
• Experience in GMP production operations and pharmaceutical/biotechnology process development or manufacturing.
• Knowledge of regulatory interactions and compliance.
• Strong technical writing, presentation, and project management skills.
• Proficiency in control charting and basic statistics.
• Availability to support non-standard shifts.
• Bilingual proficiency in English and Spanish.

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. 
In addition to the base salary, 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: 

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance 
• 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 an annual site shutdown
• 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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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 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.