Biologics PD Engineer: Process Development & Validation

Amgen SA; Holly Springs (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Amgen in North Carolina is seeking a PD Engineer to join the Process Development Drug Substance Technology group at the FleX Batch Biologics facility. You will help validate processes and support manufacturing of drug substances, contributing to technology transfer and continuous improvement.

The role requires understanding Upstream (Cell Culture) and Downstream (Purification) bioprocessing, handling deviations, and cross-functional collaboration with engineering, QA, and operations.

Qualifications

• Minimum educational background with hands-on biologics process development or validation support experience.
• Experience in Upstream/Downstream bioprocessing in regulated environments (cGMP).
• Experience with process validation, tech transfer, deviations, and CAPA.

Responsibilities

• Support bioburden and unit operation assessments in a biopharmaceutical setting.
• Contribute to process validation activities for drug substance manufacturing.
• Assist cross-functional teams in tech transfer and network practice improvements.
• Provide guidance on deviations and CAPA within manufacturing operations.
• Support process monitoring and technical studies for upstream/downstream teams.

Skills

Biologics process development

Process validation

Upstream Cell Culture

Downstream Purification

cGMP

Tech transfer

Deviations and CAPA

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

Tools

CAPA systems

Job description

Amgen in North Carolina is seeking a PD Engineer to join the Process Development Drug Substance Technology group at the FleX Batch Biologics facility. You will help validate processes and support manufacturing of drug substances, contributing to technology transfer and continuous improvement.

The role requires understanding Upstream (Cell Culture) and Downstream (Purification) bioprocessing, handling deviations, and cross-functional collaboration with engineering, QA, and operations.