Biopharma Process Eng: Solution Prep & Upstream/Downstream

BioSpace; Holly Springs (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Amgen is seeking a Process Engineer to join the Facilities & Engineering group in North Carolina. You will design, qualify, and start up systems for drug substance production, ensuring GMP compliance and operational readiness.

The role involves collaboration with regulatory inspectors, risk assessment, and implementing improvements. You will contribute to site readiness, qualification activities, and 24/7 plant reliability, with occasional travel to support global manufacturing operations.

Qualifications

• Masters degree in engineering or equivalent.
• Bachelors degree with 2+ years engineering experience or higher.
• Associates with 6+ years engineering experience.
• High school diploma with 8+ years engineering experience.

Responsibilities

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Support site readiness and startup activities to ensure GMP compliance.
• Coordinate with regulatory inspectors and ensure systems operate safely and in compliance.
• Develop maintenance programs and provide 24x7 on-call and travel support as needed.
• Assist with capital projects and ensure alignment with GMP requirements.

Skills

Engineering problem solving

Data-driven analysis

Leadership & communication

Team collaboration

Regulatory knowledge (cGMP)

Education

Masters degree in Engineering

Bachelors degree + 2 years engineering experience

Associates degree + 6 years engineering experience

High school diploma / GED + 8 years engineering experience

Job description

Amgen is seeking a Process Engineer to join the Facilities & Engineering group in North Carolina. You will design, qualify, and start up systems for drug substance production, ensuring GMP compliance and operational readiness.

The role involves collaboration with regulatory inspectors, risk assessment, and implementing improvements. You will contribute to site readiness, qualification activities, and 24/7 plant reliability, with occasional travel to support global manufacturing operations.