MSAT Engineer II: Packaging & Closure Lead

Humacyte; Durham (NC); On-site; USD 95,000 - 140,000; Full time

Benefits offered by this job

Stock Options

401k Plan with 4% Match

Medical, Vision and Dental Plans

23 Days Paid Time Off

Paid Parental Leave

Company Paid Disability & Life

Job summary

Humacyte Inc seeks an MSAT Engineer 2 to provide engineering expertise for commercial and clinical manufacturing. You will lead packaging and container-closure systems, support labeling, and drive improvements across cGMP bioprocessing.

Collaboration across Manufacturing, Quality, Facilities, and Regulatory teams is essential. The role requires a Bachelor’s degree in engineering or life sciences, 2–5 years in GMP environments, and experience with packaging materials, extractables/leachables, and

Qualifications

• GMP experience in a biopharma/bioprocessing environment.
• Experience with container closure systems and integrity testing.
• Familiarity with packaging technologies and regulatory expectations.

Responsibilities

• Serve as a process engineer for ATEV production, supporting GMP operations.
• Lead packaging and labeling engineering for container closure systems.
• Develop requirements, risk assessments, and specs for packaging equipment.
• Support selection, qualification, and lifecycle management of packaging materials.
• Participate in tech transfer, process characterization, and validation activities.
• Collaborate with Manufacturing and Quality to ensure robust cGMP controls.
• Identify improvements to packaging/workflows to boost quality and efficiency.
• Support CMC filings and regulatory interactions.
• Apply cGMP principles to technical decisions and manufacturing support.
• Troubleshoot packaging processes and test methods; perform structured studies.
• Understand container closure integrity principles and test methods.
• Work with single-use and reusable bioprocess containers.

Skills

GMP experience

Container closure systems

Bioprocessing

Cross-functional collaboration

Regulatory support

Education

Bachelor’s Degree in Engineering or Life Sciences

Tools

Extractables & leachables

Job description

Humacyte Inc seeks an MSAT Engineer 2 to provide engineering expertise for commercial and clinical manufacturing. You will lead packaging and container-closure systems, support labeling, and drive improvements across cGMP bioprocessing.

Collaboration across Manufacturing, Quality, Facilities, and Regulatory teams is essential. The role requires a Bachelor’s degree in engineering or life sciences, 2–5 years in GMP environments, and experience with packaging materials, extractables/leachables, and