Senior Associate – Single-Use Systems (Remote-Ready)

Amgen; Holly Springs (NC); On-site; USD 86,000 - 116,000; Full time

Benefits offered by this job

Flexible work models

Annual bonus

Stock-based incentives

Retirement plan

Comprehensive benefits

Job summary

Amgen is seeking a Manufacturing Senior Associate focused on Single-Use Systems (SUS) to join our FleX Batch facility in North Carolina. You will support SUS mapping, editing SOPs, and troubleshoot on the floor, coordinating investigations and ENGAGE with suppliers on EN/SICAR records.

You’ll collaborate with CI teams and end users to drive improvements in tubing, kitting, and flow, while preparing trackers and supporting cross-functional projects.

Qualifications

• Experience with Single-Use Systems (SUS) in drug substance manufacturing.
• Experience in GMP manufacturing support roles or process development.
• Ability to communicate complex technical information clearly.
• Experience with cross-functional collaboration and leadership.
• Experience with manufacturing systems and 24x7 operations.

Responsibilities

• Support New Product introduction and SUS mapping/drawing.
• Maintain and edit SUS SOPs and documents.
• Troubleshoot SUS on the floor and lead investigations.
• Initiate EN/SICAR records and coordinate with vendors.
• Manage trackers for EN/SICAR/EE and lead small projects.
• Collaborate with CI leads to drive SUS improvements.
• Engage with end users to understand material capabilities.

Skills

SUS mapping

SOP editing

Troubleshooting

Event notification

SICAR records

Cross-functional leadership

Data analysis

Written communication

Presentation skills

CI collaboration

Education

High School diploma or GED

Associate’s degree in Engineering or Operations

Bachelor’s degree in Engineering or Operations

Master’s degree

Tools

Smartsheet

Excel

Trackwise

Veeva

Visio

Lucidchart

Job description

Amgen is seeking a Manufacturing Senior Associate focused on Single-Use Systems (SUS) to join our FleX Batch facility in North Carolina. You will support SUS mapping, editing SOPs, and troubleshoot on the floor, coordinating investigations and ENGAGE with suppliers on EN/SICAR records.

You’ll collaborate with CI teams and end users to drive improvements in tubing, kitting, and flow, while preparing trackers and supporting cross-functional projects.