28 days old

Engineer

Amgen
Cambridge, MA 02138
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  • Job Code
    124219505
Amgen

Job ID: R-103874
Location: Cambridge, MA, US

Do you want to help shape the future of biopharmaceutical manufacturing? Would it interest you to work with a diverse product portfolio of life changing products in a dynamic working environment and be part of a highly motivated team of process science professionals to positively impact patients' lives? Come join us!

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient.

As an Engineer in the Drug Substance Technology & Engineering Team, 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.

This opportunity is located in Cambridge, MA.

Specific responsibilities include but are not limited to:

  • Provide solutions to a variety of technical problems of moderate scope and complexity.
  • 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.
  • Function as a technical specialist to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
  • 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.
  • Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
  • Work with consultants, architects and engineering firms on development of standard design documents.
  • 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.

Domestic and International Travel: up to 15%

Basic Qualifications

Master's degree

Or

Bachelor's degree and 2 years of Engineering or Operations experience

Or

Associate's degree and 6 years of Engineering or Operations experience

Or

High school diploma / GED and 8 years of Engineering or Operations experience

Preferred Qualifications

  • 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, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules
  • Proficient re: the analysis of data generated from an array of analytical techniques
  • Regulatory knowledge and interactions and project management skills
  • Strong oral and verbal communication and presentation skills
  • Fluency in foreign languages preferred

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient.

Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.

Advancing science and helping patients - these dual passions are ingrained in our culture. They drive our work, our values, and everything we do at Amgen. For staff around the world, our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in people's lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel, we support a variety of growth opportunities-from training and education to expanding current job responsibilities.

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, or disability status.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.



PI124219505
Posted: 2020-10-01 Expires: 2020-11-02

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Cambridge, MA 02138

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