Senior Process Engineer – Biopharma Solutions Prep/UP/DN

Amgen Inc.; Holly Springs (NC); On-site; USD 115,000 - 156,000; Full time

Job summary

Amgen Inc. in Holly Springs, NC seeks a Senior Process Engineer focused on Solution Prep, Upstream, and Downstream to design, install, and validate equipment for drug substance manufacturing.

You will own process equipment and collaborate with Manufacturing, Quality, and Process Development, leading commissioning, validation, and ongoing reliability activities. This role requires an advanced degree and 6+ years in biopharma operations, with travel up to 10%.

Qualifications

• Doctorate OR 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.

Responsibilities

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Coordinate with site design, validation, commissioning teams to ensure GMP readiness.
• Execute qualification protocols and perform performance qualification runs.
• Maintain system ownership for Solution Prep, Upstream, and Downstream operations.
• Lead improvements and upgrades to process equipment with business cases.
• Provide on-call support and travel as needed (up to 10%).

Skills

Biopharma ops

Process instrumentation

GMP knowledge

Problem solving

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Job description

Amgen Inc. in Holly Springs, NC seeks a Senior Process Engineer focused on Solution Prep, Upstream, and Downstream to design, install, and validate equipment for drug substance manufacturing.

You will own process equipment and collaborate with Manufacturing, Quality, and Process Development, leading commissioning, validation, and ongoing reliability activities. This role requires an advanced degree and 6+ years in biopharma operations, with travel up to 10%.