Bioprocess MSAT Engineer II — Process Optimization

Humacyte Global Inc; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Stock Options

401k Plan with 4% Match

Medical, Vision and Dental Plans

Paid Time Off (PTO) 23 Days

Holidays 12+ (including 2 Floating)

Paid Parental Leave

Job summary

Humacyte Inc is seeking an MSAT Engineer II to provide engineering expertise and technical support for commercial and clinical bioprocessing. The role focuses on manufacturing process support, lifecycle management, deviation investigations, CAPA development, and continuous improvement across GMP operations.

With limited supervision, you will troubleshoot issues, lead product lifecycle activities, and collaborate with Manufacturing, Facilities, Metrology, Validation, Supply Chain, QA, and Product

Qualifications

• Bachelor’s degree in engineering, life sciences or related field, or equivalent military training.
• 2–5 years in a GMP-regulated environment.
• Experience with cross-functional bioprocessing projects and equipment changes.

Responsibilities

• Provide process engineering support for Acellular Tissue Engineered Vessel (ATEV) production.
• Lead continuous improvement projects to enhance Luna200 manufacturing process.
• Develop requirements, risk assessments, and specs for equipment and single-use changes.
• Support selection and lifecycle management of product contact materials and suppliers.
• Participate in technology transfer, process characterization, and validation activities.
• Collaborate with Manufacturing and Quality to ensure robust GMP bioprocessing controls.
• Apply cGMP and regulatory guidance to technical decisions.

Skills

GMP experience

Cross-functional collaboration

Bioprocessing knowledge

Troubleshooting

Single-use systems

Education

Bachelor’s degree in Engineering, Life Sciences or related field

Tools

Single-use bioprocessing equipment

Extractables & Leachables assessments

Job description

Humacyte Inc is seeking an MSAT Engineer II to provide engineering expertise and technical support for commercial and clinical bioprocessing. The role focuses on manufacturing process support, lifecycle management, deviation investigations, CAPA development, and continuous improvement across GMP operations.

With limited supervision, you will troubleshoot issues, lead product lifecycle activities, and collaborate with Manufacturing, Facilities, Metrology, Validation, Supply Chain, QA, and Product