Senior Associate, EBR & MES for Biotech Start-Up

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work options

Retirement plan

Job summary

Amgen North Carolina is seeking a Senior Associate Manufacturing to support Electronic Batch Records during facility start-up. You will generate, edit, and validate EBRs across multiple manufacturing areas, while coordinating with operations and quality groups.

The role involves implementing MES enhancements, SOP creation, and training staff as Amgen scales up production with cutting-edge digital tools. Collaborative team environment with growth opportunities.

Qualifications

• Experience generating and editing electronic batch records (EBR).
• Familiarity with PAS-X (Korber) and MES systems.
• Knowledge of cGMP or highly regulated manufacturing environments.
• Strong written and verbal communication in technical contexts.
• Ability to support start-up manufacturing activities and SOPs.

Responsibilities

• Generate and edit Electronic Batch Records (EBR) for new or modified processes.
• Troubleshoot EBRs in real time and validate changes.
• Support MES integrations and related functionalities.
• Create and maintain EBR documentation and SOPs.
• Contribute to Lean initiatives and metric tracking.
• Assist in introducing new products and manufacturing technologies.

Skills

EBR generation

PAS-X

MES integration

Troubleshooting

Lean transformation

Microsoft Office

Education

High School/GED

Associates degree

Bachelor's degree

Master's degree

Tools

PAS-X (Korber)

EBR/MES

Delta V

Electronic Quality Systems

Job description

Amgen North Carolina is seeking a Senior Associate Manufacturing to support Electronic Batch Records during facility start-up. You will generate, edit, and validate EBRs across multiple manufacturing areas, while coordinating with operations and quality groups.

The role involves implementing MES enhancements, SOP creation, and training staff as Amgen scales up production with cutting-edge digital tools. Collaborative team environment with growth opportunities.