Engineer, Manufacturing 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.

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

In this vital role you will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Amgen manufacturing network and/or Contract Manufacturing Organizations. You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing process in a cGMP environment.

• Provide solutions to a variety of technical problems of moderate scope and complexity to enable Technology Transfer of various clinical and commercial molecules.
• Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
• Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
• Initiate and complete routine technical tasks associated with Technology Transfer.
• Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting mentorship.
• Apply engineering principles and statistical analysis, including design of experiments, in-order to address processing issues and evaluate opportunities for process improvements.
• Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system modifications.
• Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments.
• Support non-standard shift organization and extended hours, as per business needs.
• Up to 15% travel is possible - domestic and international

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an Engineer with these qualifications.

• High school diploma / GED and 8 years of Engineering or Operations experience OR
• Associate’s degree and 6 years of Engineering or Operations experience OR
• Bachelor’s degree and 2 years of Engineering or Operations experience OR
• Master’s degree

• Education background in Chemical Engineering, Bioengineering or Biotechnology
• 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes.
• Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
• Experience working with commercial manufacturer of biologics using single use technology
• Basic understanding cGMP requirements;
  Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities
• Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, MMA, CEX, Viral Filtration, UFDF, and sterile filtration among…