The Sr Engineer will be joining the Core Technologies group within Development Supply Chain, Process Development, at Amgen. This group’s mission is to provide technical leadership in implementing and advancing novel manufacturing technologies. The Sr Engineer will design, develop, and deliver advanced automation technologies to support the next generation of manufacturing systems within Amgen’s process development, clinical, and commercial GMP facilities. Process control applications and systems will be developed utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), advanced robotics and artificial intelligence as well as a variety of other embedded system prototyping tools. This role is crucial for Amgen’s success and it will be a key contributor to ensure we reliably supply medicines to our patients.
He/she will play a critical role by providing technical support and execution of automation development activities. The Sr Engineer will demonstrate expertise in hardware and software design principles, as well as serve as a primary developer for key manufacturing technologies and applications. The candidate will have broad experience in multiple automation areas and technologies including advanced robotics and AI.
The successful candidate is expected to be self-directed, with the ability to lead cross functional work, managing execution and communication / escalation relevant to the scope, schedule and cost of a given project. To be able to identify and execute successful process automation development tasks. Additionally, the role will be expected to employ novel data modeling/analysis approaches to quickly solve problems, and deliver a differentiating outcome for Amgen Operations.
- Responsible for the 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 and GMP regulated manufacturing settings.
- Lead cross-functional teams working effectively to design, develop, and troubleshoot 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.
- Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
- Support a safe working environment by complying with all pertinent environmental health/safety practices, rules and regulations.
- Doctorate degreeOR
- Master’s degree & 3 years of engineering experienceOR
- Bachelor’s degree & 6 years of engineering experienceOR
- Associate’s degree & 8 years of engineering experienceOR
- High school diploma / GED & 10 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 control system automation background focused specifically in design, installation, programming, and validation of automated processes.
- Experience in robotics – programming and design.
- Experience in Artificial Intelligence / Machine Learning / Deep Learning.
- 5+ years combined experience with the following product platforms: Emerson DeltaV DCS systems version 11 or above, Rockwell Automation Factory Talk & ControlLogix PLC Platform.
- Ability to create, update and read engineering and electrical design packages including SDS, 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 DeviceNet technologies.
- Experience with GMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.
- Experience in a matrixed team environment.
- Strong communication skills (written and verbal), relationship building, organizational, technical problem solving, and ability to regularly interact with staff from other functions.
- Ability to learn and act on dynamic information at a rapid pace.
- The ability to travel up to 20% if needed.
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.