Amgen

Senior Engineer, Drug Substance & Technology Engineering

Employer
Amgen
Location
Cambridge, MA
Posted
Jul 15, 2021
Ref
R-116096
Required Education
High School or equivalent
Position Type
Full time

As part of the Drug Substance Technology and Engineering group within the Process Development organization, one of the primary responsibilities for the senior engineer position will be to provide leadership on technical investigations in support of the global manufacturing network, using his/her process engineering and equipment design experience to assess unit operation performance and work with both suppliers and the internal network to resolve equipment and single use consumable challenges. The Sr. Engineer will lead and solve complex problems in a matrixed environment. The Sr. Engineer will analyze available data, research technical subjects, and work with other subject matter experts to support resolution of critical investigations.

Another important aspect of this role is to provide leadership on capital projects and implementation of new technologies into manufacturing. The candidate will provide process development representation on capital projects, ensuring process requirements are incorporated into equipment and facility designs. The position will support and/or lead design of flexible manufacturing equipment and single use consumables, including support of factory acceptance testing and onsite commissioning and qualification.

In addition, this role will support the Amgen single use global network as a drug substance subject matter expert. The candidate will be expected to provide leadership on various work streams related to improving robustness of design, specification, and qualification of single use consumables and equipment. He/she will lead technical assessments for supplier and internally driven changes, evaluating impact to fit and function. The candidate may also support technical visits to evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost, throughput, or other unique capabilities to Amgen manufacturing.

The position will require travel to both domestic and international vendor sites and Amgen production facilities (10-15%).

Basic Qualifications

Doctorate degree

OR

Masters degree and 3 years of Engineering or Operations experience

OR

Bachelors degree and 5 years of Engineering or Operations experience

OR

Associates degree and 10 years of Engineering or Operations experience

OR

High school diploma/GED and 12 years of Engineering or Operations experience

Preferred Qualifications

  • Masters degree and 6+ years of directly related experience
  • Strong understanding of Good Manufacturing Practices (GMP) equipment design and biologics manufacturing requirements
  • Detailed knowledge of multiple unit operations
  • Experience leading root cause analyses and troubleshooting GMP manufacturing issues
  • Ability to apply advanced problem solving skills within defined constraints
  • Experience providing process engineering support of pilot/clinical/commercial processes
  • Experience with large capital projects, including design, procurement, commissioning and qualification of production scale equipment
  • Experience with single-use component design and application in biopharmaceutical production
  • Experience developing and transferring process technology into GMP production environment
  • Excellent technical writing and verbal communication skills
  • Excellent facilitation and influencing skills

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.


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.