Senior Manufacturing Specialist, Single-Use Systems

Amgen; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Amgen North Carolina in Holly Springs is seeking a Manufacturing Senior Associate - Single Use Systems (SUS) to join the Manufacturing Support team. You will support new product introductions, SUS technology deployment, and continuous improvement projects in a high‑yield drug substance environment.

Key tasks include SUS mapping, maintaining SOPs, leading troubleshooting, and contributing to CAPA and deviation handling.

Qualifications

• Eight years of Engineering or Operations experience (or equivalent) with related GMP manufacturing exposure.
• Experience with single-use systems (SUS) and drug substance processing.
• Ability to communicate complex technical information clearly in writing and presentations.

Responsibilities

• Support New Product introduction and SUS mapping/drawing.
• Maintain and edit SUS SOPs.
• Support manufacturing and quality through SUS defect/leak triage process.
• Initiate EN/SICAR records and coordinate investigations with vendors.
• Maintain up-to-date EN/SICAR/EE trackers and manage small to medium projects.
• Collaborate with CI leads to drive SUS improvement projects.

Skills

Data analysis

Team collaboration

Technical writing

Problem solving

Education

High School diploma / GED

Associate's degree

Bachelor's degree

Master's degree

Tools

Smartsheet

Excel

Trackwise

Veeva

Visio

Lucidchart

Job description

Amgen North Carolina in Holly Springs is seeking a Manufacturing Senior Associate - Single Use Systems (SUS) to join the Manufacturing Support team. You will support new product introductions, SUS technology deployment, and continuous improvement projects in a high‑yield drug substance environment.

Key tasks include SUS mapping, maintaining SOPs, leading troubleshooting, and contributing to CAPA and deviation handling.