MSAT Engineer II — Bioprocess & Manufacturing

NCBioImpact; Durham (NC); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Stock Options

401k Plan with 4% Match and no Vesting

Medical, Vision and Dental Plans

Company Paid Long Term/Short Term  Dis

Company Paid Life Insurance

Paid PTO 23 Days

Holidays and Parental Leave

Job summary

Humacyte Inc. in Durham, NC seeks an MSAT Engineer II to provide engineering expertise and technical support for commercial and clinical bioprocessing.

You will act as a general process engineer, focusing on manufacturing process support and product lifecycle activities, with limited supervision. You will troubleshoot operations, conduct engineering studies, and lead deviation investigations, CAPA development, and lifecycle management across cross-functional teams including Manufacturing,

Qualifications

• Bachelor’s Degree in Engineering, Life Sciences or related field.
• 2–5 years working in a GMP regulated environment.
• Experience working cross functionally within a Bioprocessing organization.
• Experience with single-use bioprocessing containers and extractables/leachables considerations in GMP manufacturing.
• Experience with current commercial scale bioprocessing technologies and industry practices.
• Experience with projects related to process optimization, technical troubleshooting, and bioprocessing equipment changes.

Responsibilities

• Serves as a process engineer for Acellular Tissue Engineered Vessel (ATEV) production, providing engineering support for GMP manufacturing operations through process monitoring, equipment troubleshooting, and investigation activities.
• Leads evaluation and implementation of continuous improvement projects to enhance quality, reliability, and efficiency of the Luna200 manufacturing process.
• Develops user requirements, design requirements, risk assessments, extractables and leachables assessments, and technical specifications for equipment and single-use system changes.
• Supports selection, qualification, and lifecycle management of product contact materials and suppliers.
• Participates in technology transfer, process characterization, process validation, and continued process verification activities.
• Partners with Manufacturing and Quality to establish robust procedures and controls for cGMP bioprocessing.

Skills

Process engineering

cGMP knowledge

Troubleshooting bioprocessing

Single-use systems

Cross-functional collaboration

Lifecycle management

Analytical thinking

Education

Bachelor's Degree in Engineering or Life Sciences

Tools

Single-use bioprocess systems

Extractables & Leachables

Process validation

Job description

Humacyte Inc. in Durham, NC seeks an MSAT Engineer II to provide engineering expertise and technical support for commercial and clinical bioprocessing.

You will act as a general process engineer, focusing on manufacturing process support and product lifecycle activities, with limited supervision. You will troubleshoot operations, conduct engineering studies, and lead deviation investigations, CAPA development, and lifecycle management across cross-functional teams including Manufacturing,