Senior Biopharma Process Engineer - Remote & Flexible

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

Job summary

Amgen is currently seeking a Senior Process Engineer to join the Facilities & Engineering (F&E) group, joining corporate engineering to design, build, commission, and qualify new equipment for drug substance production. The role focuses on ensuring readiness and ownership of process systems for downstream operations.

You will partner with the team to support operations, qualification, and regulatory readiness, including audits and continuous improvement in a dynamic, 24/7 environment.

Qualifications

• Doctorate degree.
• Master’s degree with 2 years of engineering experience.
• Bachelor’s degree with 4 years of engineering experience.
• Associate’s degree with 8 years of engineering experience.
• High school diploma / GED with 10 years of engineering experience.

Responsibilities

• Provide system ownership for biopharmaceutical process equipment and improvements.
• Collaborate with Manufacturing, Quality, Process Development, and Maintenance to ensure reliable plant operations.
• Develop maintenance programs and ensure spare parts availability.
• Ensure safety, EH&S practices and regulatory compliance.
• Support GMP commissioning and qualification activities and regulatory inspections.
• Lead/root cause analysis and implement corrective/preventive actions.
• Assist with new product introductions and engineering runs.
• Provide 24x7 on-call reliability for Upstream/Downstream systems.
• Travel up to 10% domestically/internationally.

Skills

Strong leadership

Technical writing

Communication skills

Data-driven analysis

Problem solving

Education

Doctorate degree

Master’s degree + 2 years engineering experience

Bachelor’s degree + 4 years engineering experience

Associate’s degree + 8 years engineering experience

High school diploma or GED + 10 years engineering experience

Job description

Amgen is currently seeking a Senior Process Engineer to join the Facilities & Engineering (F&E) group, joining corporate engineering to design, build, commission, and qualify new equipment for drug substance production. The role focuses on ensuring readiness and ownership of process systems for downstream operations.

You will partner with the team to support operations, qualification, and regulatory readiness, including audits and continuous improvement in a dynamic, 24/7 environment.