Senior Bioprocess Engineer: Solution Prep & Downstream

BioSpace; Holly Springs (NC); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Amgen in the United States is seeking a Senior Process Engineer—Solution Prep, Upstream, and Downstream—to join the Facilities & Engineering group. You will design, commission, and qualify equipment for drug substance production, focusing on solution prep and purification steps.

The role requires advanced engineering degrees and experience in GMP environments, with domestic travel up to 10%. You will partner with global teams to ensure safe, compliant operation and on-time project delivery.

Qualifikationen

• Engineering expertise in drug substance systems and GMP operations.
• Experience leading cross-functional projects in biopharma.
• Strong writing and communication for technical documentation.

Aufgaben

• Design, build, commission, and qualify new equipment for drug substance production.
• Develop domain ownership and support process operations for Solution Prep, Upstream, and Downstream.
• Ensure systems are installed per design and compliant with GMP requirements.
• Lead commissioning, validation, and performance qualification runs.
• Provide on-call or shift support to ensure 24x7 reliability.

Kenntnisse

Leadership

Technical writing

Communication

Problem solving

Ausbildung

Doctorate degree

Masters degree + 2 years of Engineering experience

Bachelor's degree + 4 years of Engineering experience

Associates degree + 8 years of Engineering experience

High school diploma / GED + 10 years of Engineering experience

Jobbeschreibung

Amgen in the United States is seeking a Senior Process Engineer—Solution Prep, Upstream, and Downstream—to join the Facilities & Engineering group. You will design, commission, and qualify equipment for drug substance production, focusing on solution prep and purification steps.

The role requires advanced engineering degrees and experience in GMP environments, with domestic travel up to 10%. You will partner with global teams to ensure safe, compliant operation and on-time project delivery.