Senior Process Engineer - Solution Prep & Upstream/Downstream

BioSpace; Holly Springs (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Amgen is seeking a Senior Process Engineer to join the Facilities & Engineering group, focusing on Solution Prep, Upstream, and Downstream processes. You will design, install, and qualify equipment, work with corporate engineering, and ensure systems meet manufacturing and GMP requirements.

Expect cross-functional collaboration and on-site responsibilities with travel up to 10%. The role emphasizes hands-on problem solving, project leadership, and delivering compliant, reliable systems for a

Qualifications

• Doctorate or Masters with engineering experience or a Bachelors with extensive experience.
• 5+ years in Biopharmaceutical operations/manufacturing environment preferred.
• Experience with Solution Prep, Upstream, and Downstream purification equipment.

Responsibilities

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Lead commissioning and qualification to ensure operational capability and GMP compliance.
• Provide 24x7 on-call or shift support and ensure readiness of systems for operations.
• Collaborate with Manufacturing, Quality, Process Development, and Maintenance for reliable plant operations.
• Travel domestically/internationally up to 10% as required.

Skills

Process engineering

Project management

Cross-functional collaboration

Leadership

Communication

Education

Doctorate degree

Masters degree (2 years engineering experience)

Bachelors degree (4 years engineering experience)

Associates degree (8 years engineering experience)

High school diploma / GED (10 years engineering experience)

Tools

GMP systems

Job description

Amgen is seeking a Senior Process Engineer to join the Facilities & Engineering group, focusing on Solution Prep, Upstream, and Downstream processes. You will design, install, and qualify equipment, work with corporate engineering, and ensure systems meet manufacturing and GMP requirements.

Expect cross-functional collaboration and on-site responsibilities with travel up to 10%. The role emphasizes hands-on problem solving, project leadership, and delivering compliant, reliable systems for a