Amgen Inc
Manufacturing Senior Associate – Single Use Systems (SUS)
US - North Carolina - Holly Springs · Senior
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About the role
- If you feel like you're part of something bigger, it's because you are.
- It is key to our becoming one of the world's leading biotechnology companies.
- We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide.
Responsibilities
- Support New Product introduction and projects through SUS mapping/drawing.
- Maintain and edit SUS Standard Operating Procedures (SOP).
- Support manufacturing and quality through the SUS defect/leak triage process - perform troubleshooting on the floor, initiate investigations and bring leaks and defects to triage meetings.
- Maintain up-to-date EN/SICAR/Early Engagement (EE=new item) trackers and manage or lead small to medium projects.
- Support Vendor Change Notification assessments.
- Collaborate with Continuous Improvement (CI) leads to help SUS improvement projects and provide/lead use cases for continuous improvement projects. For example, improvements around tubing management, material kitting, and flow.
Requirements
- High School diploma / GED and 8 years of Engineering or Operations experience
- Associate's degree and 6 years of Engineering or Operations experience
- Bachelor's degree and 2 years of Engineering or Operations experience
Nice to have
- Experience with and understanding of Single-Use Systems.
- Technical knowledge of drug substance processing and broad understanding of related disciplinary areas.
- Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms.
- Ability to coach, mentor and/or cross train colleagues within core technical area.
- Data analysis and/or data visualization skills
- Excellent writing skills.
- Presentation experience - presentation to leadership.
- Determines work tasks and timelines self-sufficiently. ability to navigate through ambiguity and prioritize effectively
Compensation
- 86,048.05USD -116,417.95 USD
Company info
- Be part of Amgen's newest and most advanced drug substance manufacturing plant.
- In this vital role you will be part of the Manufacturing Support team which is responsible for manufacturing activities such as new product introduction, new technology and equipment introduction, continuous improvement projects, supporting CAPA ownership, deviation trending, and optimization/implementation of single use technologies.
- We are all different, yet we all use our unique contributions to serve patients.
- We are looking for a detail-oriented partner with an understanding of manufacturing operations and a passion for single-use systems, with the following qualifications:
This listing is sourced directly from Amgen Inc's careers page and normalized into a canonical job model.