Sr Engineer

Sr Engineer

This position can be based in West Greenwich, RI, Thousand Oaks, CA or Juncos, PR.

Responsible for providing project support to Raw Material Data Management, Variation Monitoring and Control Initiatives via both data driven and process analytical technology (PAT)-based methods. Also provide support to Real-time Multivariate Statistical Process Monitoring (RT-MSPM) deployment at various Amgen manufacturing sites and incorporating raw material information into the program. Provide support and leadership in Supplier Relationship Excellence programs in introducing advanced data management systems, multivariate analysis and monitoring and new technology testing while interfacing with Material Sciences and other groups including working directly with the suppliers. Position will be based either at Rhode Island, Puerto Rico or at Thousand Oaks with approximate travel requirement about 25% of the time.
As part of the GPE Process & Systems Analysis team, the successful candidate will play a role in providing leadership and deploying transformational technologies in the following ways:

• Deployment of Real-time Multivariate Statistical Process Monitoring (RT-MSPM) program across the Amgen network (Bulk Drug Substance Mfg, Formulation & Finish, Primary Containers, Small Molecules & Pilot Plants)
• Provide Data Management across product and raw material lifecycles
• Apply Process Analytical Technologies (PAT), Process Modeling, Monitoring, Control and Optimization across commercial molecules
Responsibilities include:
• Help defining and deploying data management approaches regarding our raw material suppliers
• Business Case Development for technology implementation at various Amgen sites
• Developing approaches to capture business value generated post-implementation of new technologies towards applying to new potential areas
• Support development and execution of Product Lifecycle Data Management Strategy
• Support incorporation of RT-MSPM into Quality-by-Design (QbD) program
Support includes process performance monitoring; working with the site teams to identify process improvement strategies via advanced process monitoring; development of process models; training the site and GPE teams on advanced data systems and monitoring tools; process troubleshooting using advanced data analytical techniques (including multivariate data analysis, MVDA), systems theory; process innovation via technology development and support technology transfers from process and systems perspective and applying knowledge management tools. Support efforts to resolve complex problems while meeting quality, schedule, and cost objectives. Scope will include identifying opportunities and applying real-time monitoring process analytical technologies to bulk drug substance, formulation and finish, small molecule and primary containers across global Amgen network. Perform individually and/or in teams (including lead roles). Develop business cases for technology implementation and present to peers and to upper management. Lead technology development projects including PD Lab and pilot-plant study design (including providing training and developing junior staff), Process Analytical Technologies in particular, interfacing with internal and external resources. Present technical information at internal and external scientific meetings and keep commanding knowledge of latest bioprocess monitoring and control technologies in scientific and industrial community.

Basic Qualifications
- Master's degree
OR
- Bachelor's degree & 2 years of directly related experience
OR
- Associate's degree & 6 years of directly related experience
OR
- High school diploma / GED & 8 years of directly related experience

Preferred Qualifications
Bachelor's degree required in Biochemical, or Chemical Engineering.
MS degree Biochemical or Chemical Engineering
Minimum 3 years of industry experience in cGMP biopharmaceutical or pharmaceutical manufacturing environment and/or pilot/bench-scale experience in development environment. Excellent written and verbal communication skills. Experience with production data systems, chemometrics, raw materials data, multivariate process modeling and monitoring tools and process analytical technologies are required.