Senior Process Engineer, Biologics & GMP Manufacturing

KBI Biopharma, Inc.; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC, is seeking a highly skilled Process Engineer to support cGMP operations, ensuring that manufacturing process equipment is maintained and optimized. The Process Engineer will lead projects that improve current processes and implement new processing equipment while ensuring compliance with all regulations.

The ideal candidate has a Bachelor's in chemical engineering and over 10 years of experience in bioprocess development. Strong communication and problem-solving skills are essential, along with expertise in biologics and process optimization.

Qualifications

• 10+ years of experience in bioprocess development or manufacturing within biotech.
• Expertise in biologics, cell therapy, gene therapy.
• Strong understanding of cGMP regulations and FDA/EMA guidelines.

Responsibilities

• Support equipment commissioning and qualification activities.
• Collaborate to troubleshoot and resolve equipment-related issues.
• Lead projects to improve manufacturing operations.
• Design and execute experiments for process optimization.

Skills

Bioprocess development

Manufacturing

Project management

Communication

Problem-solving

Education

Bachelor's in chemical engineering

Tools

Process modeling tools

Job description

KBI Biopharma, Inc. in Durham, NC, is seeking a highly skilled Process Engineer to support cGMP operations, ensuring that manufacturing process equipment is maintained and optimized. The Process Engineer will lead projects that improve current processes and implement new processing equipment while ensuring compliance with all regulations.

The ideal candidate has a Bachelor's in chemical engineering and over 10 years of experience in bioprocess development. Strong communication and problem-solving skills are essential, along with expertise in biologics and process optimization.