MSAT Engineer II

Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis, and peripheral arterial disease.

Preclinical development is also underway in coronary artery bypass graft, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation.

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The MSAT Engineer 2 is responsible for providing engineering expertise and technical support for Humacyte’s commercial and clinical manufacturing processes. This role serves as a general process engineer supporting all bioprocessing operations, but specifically this position will serve as the lead engineer for container closure systems, packaging, and final product labeling. With limited supervision, this position will support routine operations, execute engineering studies, troubleshoot technical issues, and lead packaging-related improvements.

This position will collaborate with Manufacturing, Facilities & Engineering, Metrology, Validation, Supply Chain, Quality Assurance, and Product Quality to ensure robust, compliant, and reliable packaging solutions.

• Serves as a process engineer for Acellular Tissue Engineered Vessel (ATEV) production, providing technical support for GMP manufacturing operations through process monitoring, troubleshooting, and investigation activities
• Leads engineering efforts for packaging and labeling operations for container closure systems used in clinical and commercial manufacturing
• Develops user requirements, design requirements, risk assessments, extractables and leachables assessments, and technical specifications for packaging equipment and container closure systems
• Supports selection, qualification, and lifecycle management of packaging 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
• Evaluates and implements continuous improvements to packaging and labeling workflows to enhance quality, reliability, and efficiency
• Supports Chemistry, Manufacturing, and Controls (CMC) filings and interactions with Regulatory Health Authorities
• Demonstrated ability to interpret and apply cGMP requirements, regulatory guidance, and pharmaceutical quality-system principles to technical decision-making, and manufacturing support.
• Able to independently troubleshoot packaging processes, equipment, and integrity-test methods and execute structured engineering studies
• Working knowledge of packaging materials, sealing processes, container closure systems, and the factors that affect closure integrity
• Demonstrated understanding of container closure integrity principles, test-method selection, method development or qualification, and data…