Senior Biopharma Process Engineer - Upstream/Downstream

Amgen; Holly Springs (NC); On-site; USD 150,000 - 210,000; Full time

Job summary

Amgen is seeking a Principal Process Engineer to join the Facilities & Engineering group in support of Upstream and Downstream drug substance operations at our Holly Springs site. You will lead equipment design, qualification, commissioning, and ongoing operations to ensure reliable manufacturing of biopharmaceutical products.

Ideal candidates have advanced degrees with 6–12 years in biopharma engineering, strong project leadership, and experience with GMP, QA, and cross-functional teams.

Qualifications

• PhD or MS in chemical/biomedical engineering or related field.
• Multiple pathways with 6–12+ years in biopharma or related industry.
• Experience in GMP regulatory environments and change control.
• Leadership or management experience required or strongly preferred.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Lead design, build, commissioning and qualification of new process equipment.
• Drive 24/7 operations readiness and engineering support for manufacturing.
• Perform risk assessments and implement CAPA for systems.
• Coordinate with QA, Manufacturing, and maintenance teams across sites.
• Develop and mentor junior engineers and manage projects end-to-end.
• Oversee validation runs and ensure on-time project delivery.

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Chromatography systems

Centrifugation equipment

Viral filtration skids

Autoclaves

CIP systems

Job description

Amgen is seeking a Principal Process Engineer to join the Facilities & Engineering group in support of Upstream and Downstream drug substance operations at our Holly Springs site. You will lead equipment design, qualification, commissioning, and ongoing operations to ensure reliable manufacturing of biopharmaceutical products.

Ideal candidates have advanced degrees with 6–12 years in biopharma engineering, strong project leadership, and experience with GMP, QA, and cross-functional teams.