Senior Process Engineer, Biopharma Operations & Equipment

Amgen; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive benefits

Collaborative culture

Job summary

Amgen is seeking a Senior Process Engineer in Holly Springs, NC to join the Facilities & Engineering group. The role involves designing, building, and qualifying equipment for drug substance production, with responsibilities spanning from commissioning to operational readiness of process engineering.

The ideal candidate will have substantial experience in biopharmaceutical manufacturing, including equipment knowledge and GMP compliance. This position requires effective collaboration across various teams, ensuring reliable operations in Upstream and Downstream processing.

Qualifications

• 6+ years’ relevant work experience in a biopharmaceutical environment.
• Experience with equipment validation and commissioning.
• Strong understanding of GMP regulations and compliance.

Responsibilities

• Support design and build of manufacturing equipment.
• Lead process engineering for plant operations.
• Collaborate with teams to ensure equipment functionality.

Skills

GMP operations

Engineering expertise

Technical writing

Leadership skills

Communication skills

Education

Doctorate degree

Master’s degree with 2 years of experience

Bachelor’s degree with 4 years of experience

Associate’s degree with 8 years of experience

High school diploma / GED with 10 years of experience

Tools

Biopharmaceutical production equipment

GMP quality systems

Clean in place (CIP) systems

Chromatography systems

Cell culture reactors

Job description

Amgen is seeking a Senior Process Engineer in Holly Springs, NC to join the Facilities & Engineering group. The role involves designing, building, and qualifying equipment for drug substance production, with responsibilities spanning from commissioning to operational readiness of process engineering.

The ideal candidate will have substantial experience in biopharmaceutical manufacturing, including equipment knowledge and GMP compliance. This position requires effective collaboration across various teams, ensuring reliable operations in Upstream and Downstream processing.