Principal Automation Engineer, Upstream/Downstream Biopharma

Amgen; Holly Springs (NC); On-site; USD 140,000 - 200,000; Full time

Job summary

Amgen is seeking a Principal Manufacturing Systems Engineer – Upstream/Downstream Process Automation to lead automation initiatives for drug substance production and to partner with engineering, manufacturing, and quality teams to implement scalable solutions for 24/7 operations.

You will design, validate, and qualify automation systems, lead IV/ACO activities, and mentor engineers while advancing site-wide automation strategies and GMP compliance.

Qualifications

• Doctorate degree and 2 years of engineering experience.
• Master’s degree and 4 years of engineering experience.
• Bachelor’s degree and 6 years of engineering experience.
• Associate’s degree and 10 years of engineering experience.
• High school diploma / GED and 12 years of engineering experience.
• 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Responsibilities

• Site design, construction, start-up, and operational readiness.
• Execute commissioning and qualification of process equipment automation in alignment with GMP requirements.
• Collaborate with the site process engineering team to develop automation solutions.
• Lead commissioning and qualification efforts, including IV/ACO.
• Mentor site automation staff and drive continuous improvement.
• Provide 24x7 automation support and cross-functional collaboration.
• Stay current with emerging technologies and industry trends.

Skills

Automation engineering

Leadership

Regulatory compliance

Process control

Manufacturing

Data integrity

Mentoring

Cross-functional collaboration

Project management

Technical communication

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Doctorate degree in Engineering

Associate’s degree + 10 years experience

Tools

DeltaV DCS

OPC

Foundation Fieldbus

GAMP standards

Job description

Amgen is seeking a Principal Manufacturing Systems Engineer – Upstream/Downstream Process Automation to lead automation initiatives for drug substance production and to partner with engineering, manufacturing, and quality teams to implement scalable solutions for 24/7 operations.

You will design, validate, and qualify automation systems, lead IV/ACO activities, and mentor engineers while advancing site-wide automation strategies and GMP compliance.