Amgen Senior Engineer, Drug Substance & Technology Engineering in Cambridge, Massachusetts
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%).
Master's degree and 3 years of Engineering or Operations experience
Bachelor's degree and 5 years of Engineering or Operations experience
Associate's degree and 10 years of Engineering or Operations experience
High school diploma/GED and 12 years of Engineering or Operations experience
Master's 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 people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.