MSAT Engineer II
About The Position
The MSAT Engineer II provides engineering expertise and technical support for Humacyte’s commercial and clinical manufacturing processes. The role serves as a general process engineer supporting bioprocessing operations, with lead responsibility for container closure systems, packaging, and final product labeling. With limited supervision, the engineer supports routine operations, conducts engineering studies, troubleshoots technical issues, and leads packaging-related improvements. The position works cross-functionally with Manufacturing, Facilities & Engineering, Metrology, Validation, Supply Chain, Quality Assurance, and Product Quality to support robust, compliant, and reliable packaging solutions. Humacyte develops and manufactures acellular tissues and other bioengineered human tissue products. Its Acellular Tissue Engineered Vessel (ATEV) portfolio includes products approved for vascular trauma repair and candidates in late-stage clinical trials for other applications. The role supports ATEV production and related commercial and clinical manufacturing operations.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or another related technical field, or equivalent military training.
- 2–5 years of experience 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.
- Ability to interpret and apply cGMP requirements, regulatory guidance, and pharmaceutical quality-system principles to technical decision-making and manufacturing support.
- Ability 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 factors affecting closure integrity.
- 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.
- Ability to work in a fast-paced team environment with fluctuating priorities and collaborate across functions.
- Strong organizational and time-management skills, including the ability to set priorities in a timely manner.
- Flexibility and adaptability.
Responsibilities
- Provide technical support for GMP ATEV manufacturing operations through process monitoring, troubleshooting, and investigation activities.
- Lead engineering efforts for packaging and labeling operations for container closure systems used in clinical and commercial manufacturing.
- Develop user requirements, design requirements, risk assessments, extractables and leachables assessments, and technical specifications for packaging equipment and container closure systems.
- Support selection, qualification, and lifecycle management of packaging materials and suppliers.
- Participate in technology transfer, process characterization, process validation, and continued process verification activities.
- Partner with Manufacturing and Quality to establish robust procedures and controls for cGMP bioprocessing.
- Evaluate and implement continuous improvements to packaging and labeling workflows to enhance quality, reliability, and efficiency.
- Support Chemistry, Manufacturing, and Controls (CMC) filings and interactions with Regulatory Health Authorities.
Benefits
- Competitive base compensation and bonus
- Stock options
- 401(k) plan with 4% match and no vesting schedule
- Medical, vision, and dental plans
- Company-paid long-term and short-term disability
- Company-paid life insurance
- Voluntary benefits, including pet insurance, hospital indemnity, accident and critical illness plans, voluntary life insurance, and legal protection plans
- 23 days of paid time off (PTO) to start
- 10 company-designated holidays plus 2 floating holidays
- Paid parental leave policies
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
