Senior Associate Manufacturing - Electronic Batch Record Support

About the role

Amgen is hiring several Senior Associates for its North Carolina manufacturing facility, which is currently starting up. The role supports the start-up of the ANC facility and focuses on generating electronic documentation, tracking EBR metrics and communicating between operations teams and the functional groups involved in start-up. It covers electronic batch record (EBR) generation, troubleshooting and validation, and contributes to Lean transformation.

Key responsibilities

• Generate, edit and troubleshoot electronic batch records in real time, and manage EBR validation for new or modified processes
• Support the implementation of new MES integrations and functionalities
• Create and maintain electronic batch records, and help optimise them to match process requirements
• Record EBR metrics and apply continuous improvement tools to support Lean transformation
• Take part in projects introducing new products and new manufacturing technologies into the plant
• During start-up, oversee EBR operational readiness across dispensing, buffer/media preparation, upstream cell culture, harvest, downstream purification, analytical testing and column packing
• Support SOP creation, review and approval, design of job aids and work instructions, and staff training

Required profile

• High school/GED and 4 years of manufacturing or operations experience, or an associate's degree with 2 years, or a bachelor's degree with 6 months, or a master's degree
• Preferred: NC BioWorks certification, biotech or pharma plant start-up experience, and cGMP or other highly regulated environment experience
• Preferred: technical understanding of upstream and/or downstream manufacturing

Required skills

• Preferred: experience with PAS X (Korber) or similar electronic batch record software, including editing and validation
• Preferred: knowledge of SAP, EBR/MES, Delta V and electronic quality systems
• Excellent technical verbal and written communication

What we offer

• Salary range of $86,048 to $116,418
• Health, dental and vision coverage, life and disability insurance, and a retirement savings plan with company contributions
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives
• Time-off plans, bi-annual company-wide shutdowns and flexible work models where possible