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Axogen

Specializes in peripheral nerve repair devices

Engineering Technician

Bioprocess & BiomanufacturingPosted on Nov 11
Full-timeVandalia, OH, USA$27.25 - $34 /hrIn-person

About the Job

Requirements

  • An associate degree in Engineering Technology, Industrial Technology, Biotechnology, Life Sciences, Mechanical Technology, Electrical Technology, or a related technical field is required.
  • Two or more years of experience in a GMP-regulated manufacturing environment, such as pharmaceutical, biotechnology, medical device, cell therapy, gene therapy, or similar, is preferred.
  • Experience supporting manufacturing equipment and troubleshooting processes is required.
  • Experience executing work orders and preparing technical documentation is required.
  • Experience supporting validation, qualification, or commissioning activities is required.
  • Experience with deviation investigations and root cause analysis is preferred.

Responsibilities

  • Execute engineering and maintenance work orders in accordance with GMP requirements and site procedures.
  • Provide hands-on support for manufacturing processes, equipment, and production technicians.
  • Troubleshoot and resolve equipment, automation, utility, and process-related issues to minimize production downtime.
  • Support root cause identification and implementation of corrective and preventive actions (CAPA).
  • Assist with process improvements focused on safety, quality, efficiency, and reliability.
  • Perform equipment inspections and routine operational assessments.
  • Support startup, commissioning, and implementation of new equipment and process improvements.
  • Execute validation and qualification protocols, including IQ, OQ, PQ, and process validation activities.
  • Author deviations, nonconformance reports, technical assessments, and investigation documentation.
  • Participate in root cause investigations using structured problem-solving methodologies.
  • Collect and analyze data to support equipment and process trending or investigations.
  • Perform selected manufacturing process steps as required.
  • Provide technical guidance and hands-on assistance to production technicians during routine and non-routine manufacturing activities.
  • Support audit preparation and participate in internal and external inspections as required.

Desired Qualifications

  • Two or more years of experience in a GMP-regulated manufacturing environment, such as pharmaceutical, biotechnology, medical device, cell therapy, gene therapy, or similar.
  • Experience with deviation investigations and root cause analysis.

About the Company

Axogen

Specializes in peripheral nerve repair devices

AxoGen develops and sells surgical solutions for peripheral nerve repair. Its core products include Avance Nerve Graft, a processed human nerve allograft that bridges nerve gaps without a second surgical site, and Axoguard devices for nerve coaptation, protection, and neuroma reduction. The products are distributed directly to hospitals and surgical centers, targeting plastic, hand, and oral/maxillofacial surgeons. The goal is to improve nerve repair outcomes and grow a sustainable business in the U.S. nerve repair market by offering clinically proven, FDA-cleared tissue grafts and devices.

Company size
501-1,000
Company stage
IPO
Headquarters
Alachua, FL
Founded
2002

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