Senior Process Engineer - Upstream/Downstream

Biopharma Careers; Holly Springs (MS); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen is seeking a Principal Process Engineer for Upstream/Downstream to design, build, and qualify systems for drug substance production. You will lead projects, drive manufacturing improvements, and mentor engineers across 24/7 operations.

You will collaborate with global engineering, manufacturing, and quality teams to ensure compliance with GMP and regulatory requirements while delivering safe, efficient processes at scale.

Qualifications

• Doctorate or Master’s with relevant engineering experience, or a Bachelor’s with extensive experience.
• Experience in biopharmaceutical manufacturing and GMP environments.
• Demonstrated leadership and project management capabilities.
• Strong understanding of process design, commissioning, and qualification.

Responsibilities

• Lead design, build, commission, and qualification of new drug-substance equipment and systems.
• Manage technical projects and drive innovation in manufacturing processes.
• Provide ownership for upstream and downstream drug-substance operations.
• Mentor junior engineers and coordinate cross-functional teams across 24/7 operations.
• Ensure compliance with GMP, safety, and environmental regulations.

Skills

Process engineering

Biopharmaceutical ops

Leadership

GMP

Project management

Regulatory compliance

Education

Bachelor's degree in Chemical or Mechanical Engineering or related field

Master's degree preferred

Doctorate considered

Job description

Amgen is seeking a Principal Process Engineer for Upstream/Downstream to design, build, and qualify systems for drug substance production. You will lead projects, drive manufacturing improvements, and mentor engineers across 24/7 operations.

You will collaborate with global engineering, manufacturing, and quality teams to ensure compliance with GMP and regulatory requirements while delivering safe, efficient processes at scale.