About the Position

Manufacturing Senior Associate – Single Use Systems (SUS)

US - North Carolina - Holly Springs

Job ID: R-257044

Work Location Type: On Site

Date Posted: Oct. 14, 2026

Category: Manufacturing

Salary Range: 86,048.05 USD - 116,417.95 USD

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HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission-to serve patients-drives all that we do. 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. It’s time for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

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.
Initiate Event Notification (EN)/Supplier Investigation/Corrective Action (SICAR) records and follow process to conclusion, including collaborating with vendors on investigation.
Maintain up-to-date EN/SICAR/Early Engagement (EE=new item) trackers and manage or lead small to medium projects.
Provide input for ANC representative to SUS network for improvements and troubleshooting.
Support Vendor Change Notification assessments.
Understand single-use material capabilities and user requirements for new technologies through interaction with end users.
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

Basic Qualifications:

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
Master’s degree

Preferred Qualifications:

Experience with and understanding of Single-Use Systems.
Experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent.
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.
Team player - Ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities.
Ability to drive results through leadership of cross-functional teams.
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
Experience in computerized systems for example, Smartsheet, Excel, Trackwise, Veeva, Visio, Lucid Chart.
Expertise with translating business/user needs to user requirements and recommend solutions.
Experience in individually supporting key manufacturing systems with 24x7 operations.
The ability/experience of working in fast paced manufacturing environment where issues must be assessed, understood, and resolved immediately to be able to adapt quickly to the demands of commercial manufacturing operations.
Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, and quality.
Pro-active, results oriented, and ability to prioritize work to meet timelines.

We Offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

About the Company

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Apply now

for a career that defies imagination

careers.amgen.com

Manufacturing Senior Associate – Single Use Systems (SUS)

Job description