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Manufacturing Specialist

1 week ago

Winchester, Massachusetts, United States Vaxess Technologies Full time

**About Vaxess Technologies**

Vaxess Technologies is a NIH and venture-funded company developing a pipeline of next-generation vaccines and therapeutics on the MIMIX platform. This innovative technology enables up to two weeks of sustained delivery with only five minutes of wear-time on the skin.

We are committed to enabling products that are not only more effective, but also more accessible to patients around the world. Our cross-disciplinary research & development team integrates mechanical, industrial, biomedical, and chemical engineering with chemistry, biology, and human factors to address important unmet medical needs.

This role offers a unique opportunity to build manufacturing capacity from the ground up to bring innovative technology to the global vaccine and therapeutic market. As a skilled technician with expertise in medical device or pharmaceutical manufacturing, you will be part of our growing team and contribute to the success of our mission.

**Responsibilities**

  • Perform cGMP manufacturing operations according to documented procedures or batch records.
  • Operate automated manufacturing equipment and record relevant in-process data.
  • Complete production and testing records following Good Documentation Practices (GDP).
  • Handle, assemble, and visually inspect products, including use of a microscope, automated inspection systems, or other optical systems.
  • Contribute to root cause analysis (RCA) and help contribute to manufacturing investigations.
  • Support manufacturing related R&D efforts as needed.

**Qualifications**

  • 2+ years' relevant experience working in regulated environments in medical device or biopharmaceutical industries; experience working in a clean room is preferred.
  • High school diploma minimal, associate's degree or trade certifications preferred.
  • Good written and verbal communication skills, attention to detail, and a demonstrated ability to work effectively within a team.
  • Ability to stand or sit for a full shift on a manufacturing line.
  • Entrepreneurial spirit and drive to positively impact global human health.