Biopharma Process Engineer — GMP Upstream/Downstream

BioSpace; Holly Springs (NC); On-site; USD 90,000 - 140,000; Full time

Job summary

Amgen is seeking a Process Engineer in North Carolina to join the Facilities & Engineering team. You will design, build, commission, and qualify drug substance production equipment and support start-up readiness.

The role requires GMP knowledge, experience with Upstream/Downstream purification, and the ability to analyze problems using data-driven methods. Travel up to 10% may be needed as part of 24/7 operations.

Qualifications

• Masters degree is required or a Bachelor’s degree with 2 years of engineering experience.
• Associates degree with 6 years of engineering experience.
• High school diploma / GED with 8 years of engineering experience.
• Experience with GMP Biopharmaceutical production equipment and systems.
• Data-driven problem solving (RCA, SPC, Six Sigma) and strong teamwork.

Responsibilities

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Support commissioning and qualification in line with GMP and regulators.
• Ensure systems operate safely and comply with EH&S and GMP requirements.
• Interact with regulatory inspectors to demonstrate compliance of operating systems.
• Assist with new product/technology introductions and engineering runs.
• Provide 24/7 on-call support for solution prep, upstream, and downstream operations.

Job description

Amgen is seeking a Process Engineer in North Carolina to join the Facilities & Engineering team. You will design, build, commission, and qualify drug substance production equipment and support start-up readiness.

The role requires GMP knowledge, experience with Upstream/Downstream purification, and the ability to analyze problems using data-driven methods. Travel up to 10% may be needed as part of 24/7 operations.