Principal Process Engineer - Upstream/Downstream

Amgen; Holly Springs (NC); On-site; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics is seeking a Principal Process Engineer to lead the design, construction, commissioning, and qualification of equipment for drug substance production at a new advanced facility. The role spans upstream and downstream biopharmaceutical processing with emphasis on process equipment design and site readiness.

The ideal candidate has a PhD/advanced degree with significant engineering leadership experience in GMP environments, familiarity with Tech Transfer, and hands-on

Qualifications

• Doctorate, Master’s, Bachelor’s or equivalent engineering experience.
• 2+ years managerial or leadership experience.
• Proven expertise in biopharmaceutical process and plant engineering, including GMP environments, equipment such as reactors, centrifuges, chromatography, filtration, and associated systems.
• Familiarity with Tech Transfer, process validation, and commissioning.

Responsibilities

• Lead technical projects and support site design, construction, start-up and operational readiness.
• Oversee GMP-compliant system installation and validation.
• Provide end-to-end support for process equipment including upstream/downstream systems; lead process optimization and troubleshooting.
• Support technology transfers, process design, and new product introductions.
• Ensure regulatory compliance and safety standards.
• Mentor junior engineers.
• Support 24/7 operations with on-call duties.

Skills

Leadership

Project management

Regulatory compliance

Mentoring

Process optimization

Troubleshooting

Communication

Education

Doctorate

Master’s

Bachelor’s

Tools

GMP environments

Process validation

Commissioning

Tech Transfer

Job description

Role

Principal Process Engineer specializing in upstream/downstream biopharmaceutical manufacturing, focused on designing, building, commissioning, and qualifying equipment for drug substance production at a new advanced facility.

Responsibilities

lead technical projects, support site design, construction, start-up, and operational readiness; oversee GMP-compliant system installation and validation; provide end-to-end support for process equipment including upstream/downstream systems, and lead process optimization and troubleshooting; support technology transfers, process design, and new product introductions; ensure regulatory compliance and safety standards; mentor junior engineers; and support 24/7 operations with on-call duties.

Requirements

Doctorate (2+ years), Master’s (4+ years), Bachelor’s (6+ years), or equivalent experience in engineering; 2+ years managerial or leadership experience; proven expertise in biopharmaceutical process and plant engineering, including GMP environments, equipment such as reactors, centrifuges, chromatography, filtration, and associated systems; familiarity with Tech Transfer, process validation, and commissioning.

Preferred

degree in Chemical or Mechanical Engineering; 8+ years industry experience, especially with biologics manufacturing; hands-on experience with GMP equipment, process automation, and safety standards; excellent leadership, communication, and project management skills.

High-Value

High-Value: biologics, upstream/downstream processing, GMP, process validation, equipment design, Tech Transfer, 24/7 manufacturing support, and international travel (up to 10%).

Location

Location: not specified, travel required.