Senior Biopharma Process Engineer: GMP & 24/7 Ops

BioSpace; Holly Springs (NC); On-site; USD 120,000 - 175,000; Full time

Job summary

Amgen is seeking a Senior Process Engineer to join the Facilities & Engineering group, partnering with corporate engineering to design, build, commission, and qualify new equipment for drug substance production. You will develop domain expertise and system ownership to support operations in Solution Prep, Upstream, and Downstream.

The role requires collaboration with manufacturing, QA, and maintenance, ensuring readiness for audits and compliance with GMP requirements.

Qualifications

• Doctorate, MSc or Bachelors pathways with required years of engineering experience as stated in the job ad.
• Experience with GMP Biopharmaceutical Production facility equipment and systems.

Responsibilities

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Support process operations focusing on Solution Prep, Upstream, and Downstream.
• Lead technical reviews, commissioning, qualification runs, and assist with validation activities.

Skills

Chemical Engineering

Biopharma ops

Process engineering

GMP compliance

Education

Doctorate degree

Masters degree with 2 years engineering experience

Bachelors degree with 4 years engineering experience

Associates degree with 8 years engineering experience

High school diploma / GED with 10 years engineering experience

Job description

Amgen is seeking a Senior Process Engineer to join the Facilities & Engineering group, partnering with corporate engineering to design, build, commission, and qualify new equipment for drug substance production. You will develop domain expertise and system ownership to support operations in Solution Prep, Upstream, and Downstream.

The role requires collaboration with manufacturing, QA, and maintenance, ensuring readiness for audits and compliance with GMP requirements.