Engineering Technician
Axogen
Summary
The Engineering Technician is responsible for providing hands-on technical support within a GMP manufacturing environment. This role executes maintenance and engineering work orders, supports validation and qualification activities, troubleshoots equipment and process issues, and drives continuous improvement efforts. The Engineering Technician serves as a key resource between Manufacturing, Quality, Maintenance, and Engineering by supporting day-to-day operations, conducting investigations, documenting technical activities, and ensuring compliance with GMP requirements.
Job description
Job Summary of the Engineering Technician
The Engineering Technician is responsible for providing hands-on technical support within a GMP manufacturing environment. This role executes maintenance and engineering work orders, supports validation and qualification activities, troubleshoots equipment and process issues, and drives continuous improvement efforts. The Engineering Technician serves as a key resource between Manufacturing, Quality, Maintenance, and Engineering by supporting day-to-day operations, conducting investigations, documenting technical activities, and ensuring compliance with GMP requirements.
Responsibilities of the Engineering Technician
- 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 utilizing structured problem-solving methodologies.
- Collect and analyze data to support equipment/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.
Requirements
- Associate degree in Engineering Technology, Industrial Technology, Biotechnology, Life Sciences, Mechanical Technology, Electrical Technology, or related technical field.
- 2+ years of experience in a GMP-regulated manufacturing environment (pharmaceutical, biotechnology, medical device, cell therapy, gene therapy, or similar) preferred.
- Experience supporting manufacturing equipment and process troubleshooting.
- Experience executing work orders and technical documentation.
- Experience supporting validation, qualification, or commissioning activities.
- Experience with deviation investigations and root cause analysis preferred.
Benefits
- Health, Dental & Vision
- Matching 401(k)
- Paid Time Off
- 9 Paid Holidays + 3 Floating Holidays
- Dependent Care FSA
- Medical FSA
- Tuition Reimbursement
- Paid Parental Leave
- Paid Caregiver Leave
- Basic Life Insurance
- Supplemental Life Insurance
- Employee Stock Purchase Plan
- Disability Insurance
- Annual Performance Bonus
Company overview
Axogen, Inc. (NASDAQ: AXGN) is a leading medical device company exclusively focused on the science, development, and commercialization of innovative technologies for peripheral nerve regeneration and repair. As the only company solely dedicated to peripheral nerve repair, Axogen has pioneered a comprehensive portfolio of clinically proven solutions that address various types of nerve injuries. The company's flagship product, Avance Nerve Graft, is a biologically active processed human nerve allograft designed for bridging severed peripheral nerves without requiring a second surgical site. Axogen's product line also includes the Axoguard family of products - Nerve Connector, Nerve Protector, and Nerve Cap - which utilize porcine extracellular matrix technology to protect and repair damaged nerves. With operations in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and other countries, Axogen is committed to restoring nerve function and improving quality of life for patients suffering from peripheral nerve injuries through innovative, clinically validated, and economically effective surgical solutions.