Senior Associate: Electronic Batch Records (EBR) Support

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

Benefits offered by this job

Total Rewards Plan

Stock-based long-term incentives

Discretionary annual bonus program

Flexible work models

Job summary

Amgen is hiring for a Senior Associate Manufacturing - Electronic Batch Record Support to help start up and operate the new FleX Batch facility. You will generate and manage electronic batch records, troubleshoot in real time, and support MES integrations during startup of the ANC site and other manufacturing areas.

The role requires hands-on experience with EBRs (PAS-X), strong documentation skills, and collaboration across operations and quality.

Qualifications

• High School/GED and 4 years of manufacturing or operations experience, OR an Associate’s Degree with 2 years’ experience, OR a Bachelor’s Degree with 6 months’ experience, OR a Master’s Degree.
• Completion of NC BioWorks Certification Program.
• Experience in biotechnology or pharmaceutical plant start up.
• Knowledge of a cGMP manufacturing facility or other highly regulated environment.
• Technical understanding of upstream and/or downstream manufacturing in biotech.
• Excellent verbal and written communication (technical) skills.
• Proficient with Microsoft Office; knowledge of SAP, EBR/MES, DeltaV, and Electronic Quality Systems.
• Experience with PAS X (Korber) or comparable software for electronic batch records.

Responsibilities

• Manufacturing support focused on Electronic Batch Record (EBR) generation using PAS-X (Korber), editing, real-time troubleshooting and managing the EBR validation for new or modified processes.
• Assist in the implementation of new MES integrations and functionalities.
• Support manufacturing in the troubleshooting and execution of EBRs
• Create and maintain Electronic Batch Records
• Support optimization of EBRs to improve functionality and align with process requirements
• Contribute to Lean Transformation through recording EBR metrics and application of continuous improvement tools.
• Participate and contribute to projects to introduce new products and/or advancement of new manufacturing technologies into the plant.

Education

High School/GED

Associate’s Degree

Bachelor’s Degree

Master’s Degree

Tools

SAP

EBR/MES

DeltaV

Electronic Quality Systems

PAS X (Korber)

Job description

Amgen is hiring for a Senior Associate Manufacturing - Electronic Batch Record Support to help start up and operate the new FleX Batch facility. You will generate and manage electronic batch records, troubleshoot in real time, and support MES integrations during startup of the ANC site and other manufacturing areas.

The role requires hands-on experience with EBRs (PAS-X), strong documentation skills, and collaboration across operations and quality.