Senior Associate Manufacturing - Electronic Batch Record Support

Role Summary

Senior Associate Manufacturing - Electronic Batch Record Support. Support the start-up of the Amgen North Carolina manufacturing facility by generating electronic documentation, tracking EBR metrics, and coordinating communication between operations teams and functional groups during start-up activities. Oversight of electronic batch records readiness across multiple manufacturing areas and involvement in SOP creation, job aids, digital tools development, and staff training.

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.
• Generation of paper process documents when required.
• 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.

Qualifications

• Required: High School/GED and 4 years of manufacturing or operations work experience OR
• Required: Associate’s Degree and 2 years of manufacturing or operations work experience OR
• Required: Bachelor’s Degree and 6 months of manufacturing or operations work experience OR
• Required: Master’s Degree

• Preferred: Completion of NC BioWorks Certification Program.
• Preferred: Experience in biotechnology or pharmaceutical plant start up.
• Preferred: Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment.
• Preferred: Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation.
• Preferred: Excellent verbal and written communication (technical) skills.
• Preferred: Proficient Microsoft Office skills, and knowledge of other electronic systems such as SAP, EBR/MES, Delta V, and Electronic Quality Systems.
• Preferred: Experience with PAS X (Korber) or comparable software for electronic batch records with some understanding of editing and validation.

Education

• High School/GED
• Associate’s Degree
• Bachelor’s Degree
• Master’s Degree

Skills

• Electronic Batch Records (EBR) and MES systems
• PAS X (Korber) or equivalent software
• Documentation generation and editing
• Process documentation and SOP development
• Analytical and troubleshooting abilities
• Strong communication (technical) skills

Additional Requirements

• None specified beyond role qualifications.