Senior Process Engineer: Drug Substance Ops

Biopharma Careers; Holly Springs (MS); On-site; USD 115,000 - 156,000; Full time

Job summary

Amgen in Mississippi is seeking a Senior Process Engineer for Solution Prep, Upstream, and Downstream to design, build, commission, and qualify equipment for drug substance production. You will partner with the facilities and engineering teams to ensure compliant, scalable manufacturing operations.

The role requires experience with process equipment, commissioning, validation, and adherence to cGMP standards. Expect 10% travel and readiness for audits and continuous improvements.

Qualifications

• Doctorate or Master’s with engineering experience in biopharma environments.
• Bachelor’s degree with 4+ years of engineering experience; alternative credentials accepted.
• Experience with GMP, equipment design, commissioning, and validation preferred.

Responsibilities

• Design, build, and qualify drug-substance production equipment.
• Lead commissioning activities and ensure systems meet GMP and safety standards.
• Collaborate with corporate engineering for site readiness and project execution.
• Provide on-call support and travel up to 10% as required.

Skills

Process engineering

Biopharma ops

GMP knowledge

Leadership

Education

PhD in Engineering

Master's in Engineering

Bachelor's in Engineering

Associate's in Engineering

High school diploma

Job description

Amgen in Mississippi is seeking a Senior Process Engineer for Solution Prep, Upstream, and Downstream to design, build, commission, and qualify equipment for drug substance production. You will partner with the facilities and engineering teams to ensure compliant, scalable manufacturing operations.

The role requires experience with process equipment, commissioning, validation, and adherence to cGMP standards. Expect 10% travel and readiness for audits and continuous improvements.