Senior Associate Manufacturing - Electronic Batch Record Support

About the role

Join Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleX Batch facility combines the latest disposable technologies with traditional stainless-steel equipment for maximum operational flexibility. This facility features best-in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and integrates sustainability innovations to reduce carbon and waste as part of Amgen's plan to be a carbon-neutral company by 2027.

In this role, you will support the start-up of the Amgen North Carolina (ANC) manufacturing facility, focusing on electronic batch record (EBR) support. You will oversee EBR operational readiness activities across multiple manufacturing areas, including Dispensing, Buffer/Media Preparation, Upstream Cell Culture, Harvest, Downstream Purification, Analytical Testing, and Column Packing.

Responsibilities

• Support manufacturing in the generation, editing, real-time troubleshooting, and validation of Electronic Batch Records (EBR) using PAS-X (Körber).
• Assist in the implementation of new MES integrations and functionalities.
• Create and maintain Electronic Batch Records and generate paper process documents when required.
• Contribute to Lean Transformation by recording EBR metrics and applying continuous improvement tools.
• Participate in projects to introduce new products and/or advance new manufacturing technologies into the plant.
• Support Standard Operating Procedure (SOP) creation, review, and approval, as well as the design of job aids and work instructions.
• Advance digital tools to support manufacturing operations and train staff.

Requirements

We seek a collaborative team player with the following qualifications:

• Basic Qualifications:
  • High School/GED and 4 years of manufacturing or operations work experience, OR
  • Associate’s Degree and 2 years of manufacturing or operations work experience, OR
  • Bachelor’s Degree and 6 months of manufacturing or operations work experience, OR
  • Master’s Degree.
• Preferred Qualifications:
  • Completion of NC BioWorks Certification Program.
  • Experience in biotechnology or pharmaceutical plant start-up.
  • Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment.
  • Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation.
  • Excellent verbal and written communication (technical) skills.
  • Proficient Microsoft Office skills and knowledge of electronic systems such as SAP, EBR/MES, Delta V, and Electronic Quality Systems.
  • Experience with PAS-X (Körber) or comparable software for electronic batch records, including editing and validation.

Benefits

Amgen offers competitive and comprehensive Total Rewards Plans aligned with local industry standards. From base salary to collaborative culture, we support your professional and personal growth and well-being at every step.