Amgen is seeking a Senior Engineer to lead the automation team within Cambridge pilot plant. This individual will be responsible for developing automation strategies for cell culture and purification equipment being applied to Amgen’s next generation manufacturing platforms. The Cambridge Pilot Plant, also referred to the Scale Up Lab (SUL), is Amgen’s center of excellence for advancing new technologies while also executing cell culture and purifications operations to support Amgen’s pipeline as well as commercial manufacturing lifecycle management.
This role will support the operations team and automation infrastructure within the lab, leading and delivering projects, and contributing to technology advancement. The Senior Engineer reports to the Sr. Manager of the SUL and will be an integral member of the team’s leadership and will have some direct management responsibilities.
+ Application of advanced automation engineering principles in the design, specification, development, and testing of process equipment and systems.
+ Employ industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
+ Execute and document primary data packages related to new technology development, while demonstrating specific expertise in drug substance processing and unit operations characterization.
+ Author and review technical protocols, reports, and relevant documentation.
+ Ownership and administration of process control automation in process development manufacturing settings.
+ Lead multi-functional teams working effectively to design, develop, and solve process control issues related to electrical, instrumentation and control systems.
+ Design and test of newly installed and currently installed automation-based process equipment. Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.
+ Manage and/or act as automation or technical lead for departmental projects, while following standard project delivery methods.
+ Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
+ Support a safe working environment by following all pertinent environmental health/safety practices, rules and regulations
+ Doctorate degree
+ Master’s degree and 3 years of Engineering experience
+ Bachelor’s degree and 5 years of Engineering experience
+ Associate’s degree and 10 years of Engineering experience
+ High School Diploma/GED and 12 years of Engineering experience
+ B.S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.
+ Strong Delta V control system automation background focused specifically in design, installation, programming, and validation of automated processes.
+ 5+ years combined experience with the following product platforms: Emerson DeltaV DCS systems version 11 or above, Rockwell Automation Factory Talk & ControlLogix PLC Platform. (DeltaV preferred)
+ Ability to create, update and read engineering and electrical design packages including P&ID, URS, FS, SDS, IQ, OQ, and VSR among other engineering and validation documentation.
+ Knowledge of ASTM 2500, S88 and S95 techniques.
+ Experience in developing automation strategies for New Product Introduction and New Technology Deployment.
+ Working knowledge of manufacturing IT networks, data historians, electronic batch records, OPC, Profibus, and ethernet based BUS technologies.
+ Experience with GMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.
+ Experience in a matrixed team environment.
+ Ability to learn and act on dynamic information at a rapid pace.
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.
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.