Senior Biopharma Process Engineer — Downstream Excellence

Amgen; Holly Springs (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Flexible work models

Competitive benefits

Job summary

Amgen is seeking a Senior Process Engineer in Holly Springs, NC, to join the Facilities & Engineering group and collaborate with the corporate engineering team. The role focuses on downstream process engineering, equipment design, commissioning, and qualification for drug substance production.

You will own projects, lead process improvements, and support 24/7 operations, while ensuring safety, regulatory compliance, and effective communication with cross-functional teams.

Qualifications

• Doctorate degree required.
• Master's degree with 2+ years engineering experience.
• Bachelor's degree with 4+ years engineering experience.
• Associate's degree with 8 years engineering experience.
• High school diploma / GED with 10 years engineering experience.
• Biopharma operations experience preferred.

Responsibilities

• Own Biopharmaceutical process equipment and lead improvements or upgrades.
• Collaborate with Manufacturing, Quality, Process Development, Maintenance for reliable operations.
• Develop equipment maintenance programs and ensure spare parts availability.
• Ensure safety and GMP compliance for systems and facilities.
• Lead commissioning and qualification aligned with GMP requirements.
• Provide technical problem solving and root cause analyses to reduce downtime.

Skills

Biopharma process engineering

Leadership

Cross-functional

Root Cause Analysis

Data analytics

Project management

Communication

Travel readiness

Education

Doctorate degree

Master's degree in Engineering

Bachelor's degree in Engineering

Associate's degree

High school diploma / GED

Job description

Amgen is seeking a Senior Process Engineer in Holly Springs, NC, to join the Facilities & Engineering group and collaborate with the corporate engineering team. The role focuses on downstream process engineering, equipment design, commissioning, and qualification for drug substance production.

You will own projects, lead process improvements, and support 24/7 operations, while ensuring safety, regulatory compliance, and effective communication with cross-functional teams.