MSAT Engineer II

DEPARTMENT: MSAT

LOCATION: Durham, NC; Onsite/Not Remote

COMPANY: 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. For more information, visit www.Humacyte.com.

JOB SUMMARY:

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.

RESPONSIBILITIES:

• 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

Special Competencies

• 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 interpretation
• Familiarity with single-use and reusable bioprocess containers, including bags, bottles, tubing assemblies, connectors, and ports
• Strong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross functional teams
• Excellent organizational and time management skills with a keen ability to set own priorities in a timely manner
• High degree of flexibility and adaptability

QUALIFICATIONS:

• Bachelor's Degree in Engineering, Life Sciences or other related technical field, required, or equivalent military training
• 2-5 years working in a GMP regulated environment
• Experience working cross functionally within a Bioprocessing organization
• Experience with container closure systems, container closure integrity testing, bioprocess containers, and extractables and leachables considerations in GMP manufacturing.
• Familiarity with current pharmaceutical packaging technologies, materials, and industry practices
• Experience with projects related to process optimization, technical troubleshooting, and bioprocessing equipment changes

COMPENSATION & BENEFITS HIGHLIGHTS:

• Competitive base compensation and bonus
• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• Assortment of other voluntary benefits, including pet insurance; hospital indemnity; accident & critical illness plans; voluntary life insurance; legal protection plans and more
• 23 Days Paid Time Off (PTO) to start
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters.

The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.