Biopharma Process Engineer - GMP Systems & Startups

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 88,000 - 119,000; Full time

Job summary

Amgen Inc. (IR) seeks a Process Engineer for Solution Prep, Upstream, and Downstream to partner with Facilities & Engineering to design, install, and qualify equipment for biopharmaceutical production. You’ll support commissioning, regulatory readiness, and ongoing operation readiness for manufacturing systems.

The role emphasizes problem-solving, data-driven improvements, and collaboration in a 24/7 setting, with travel as needed to support global plant operations.

Qualifications

• Engineering experience in regulated environments is preferred.
• Knowledge of GMP Biopharmaceutical production facilities is advantageous.
• Strong communication, leadership, and project management skills.

Responsibilities

• Support design, build, commission, and qualification of manufacturing systems for drug substance production.
• Provide 24/7 operations reliability support for Solution Prep, Upstream and Downstream systems.
• Lead risk assessment and implement corrective/preventive actions.
• Coordinate with regulatory inspectors and support validation activities.
• Travel up to domestic/international locations as required.

Job description

Amgen Inc. (IR) seeks a Process Engineer for Solution Prep, Upstream, and Downstream to partner with Facilities & Engineering to design, install, and qualify equipment for biopharmaceutical production. You’ll support commissioning, regulatory readiness, and ongoing operation readiness for manufacturing systems.

The role emphasizes problem-solving, data-driven improvements, and collaboration in a 24/7 setting, with travel as needed to support global plant operations.