Senior Process Engineer - Biopharma Upstream/Downstream Lead

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

Job summary

Amgen Inc. seeks a Senior Process Engineer for Solution Prep, Upstream, and Downstream drug substance production.

You will partner with Facilities & Engineering to design, build, commission, and qualify equipment, ensuring systems meet GMP and safety standards. The role requires advanced degrees and extensive biopharmaceutical manufacturing experience, with a focus on process equipment, technology transfer, and CQV activities.

Qualifications

• Doctorate degree OR Master’s degree and 2 years of Engineering experience
• Bachelor’s degree and 4 years of Engineering experience
• Associate’s degree and 8 years of Engineering experience
• High school diploma / GED and 10 years of Engineering experience
• Degree in Chemical or Mechanical Engineering (preferred)

Responsibilities

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Lead commissioning and validation to ensure regulatory compliance and readiness.
• Provide end-to-end support for Solution Prep, Upstream, and Downstream processes.
• Coordinate with Manufacturing, Quality, Process Development, and Maintenance for reliable operations.
• Develop maintenance programs and manage spare parts to keep systems ready.
• Travel up to 10% domestically/internationally.

Skills

Leadership

Communication

Teamwork

Problem-solving

Education

Doctorate degree

Master’s degree in Engineering

Bachelor’s degree in Engineering

Associate’s degree

High school diploma or GED

Tools

P&ID diagrams

GMP systems

QA/QC documentation

Job description

Amgen Inc. seeks a Senior Process Engineer for Solution Prep, Upstream, and Downstream drug substance production.

You will partner with Facilities & Engineering to design, build, commission, and qualify equipment, ensuring systems meet GMP and safety standards. The role requires advanced degrees and extensive biopharmaceutical manufacturing experience, with a focus on process equipment, technology transfer, and CQV activities.