Senior Associate Manufacturing - Electronic Batch Record Support (Multiple Positions)

Senior Associate Manufacturing role supporting the start-up of Amgen's North Carolina manufacturing facility. Responsible for electronic batch record generation, validation, and operational readiness across multiple manufacturing areas including upstream cell culture, downstream purification, and analytical testing.

Responsibilities

• Generate, edit, and troubleshoot electronic batch records using PAS-X software
• Support MES integrations and manage EBR validation for new or modified processes
• Track and report EBR metrics to support continuous improvement initiatives
• Assist with SOP creation, job aids design, and staff training across manufacturing areas
• Collaborate on projects introducing new products and manufacturing technologies

Requirements

• High school diploma/GED plus 4 years manufacturing or operations experience
• Knowledge of electronic batch record systems, preferably PAS-X (Korber)
• Experience in cGMP manufacturing or regulated environments
• Strong technical writing and verbal communication skills
• Proficiency with Microsoft Office and EBR/MES software systems
• Understanding of upstream and/or downstream biotechnology manufacturing processes

Compensation: $86,048–$116,418 base