Manufacturing Technician - Equipment & Launch Readiness

Elutia; Gaithersburg (MD); On-site; USD 65,000 - 90,000; Full time

Job summary

Elutia is seeking a Manufacturing Technician, Equipment & Operations to join its growing Operations team. You will help establish manufacturing operations, prepare for a commercial launch, and support ongoing production of combination products with hands-on equipment work.

You will troubleshoot, calibrate, and maintain equipment, transfer processes from R&D to Manufacturing, and train new operators while helping ensure GMP compliance and quality throughout scale-up.

Qualifications

• Bachelor's degree in Engineering, Engineering Technology, Manufacturing, Life Sciences, or related field.
• 2-4 years of experience in manufacturing, operations, engineering support, or related technical environment.
• Experience in medical device, pharmaceutical, biotechnology, combination product, or other regulated manufacturing environment preferred.
• Strong mechanical and technical aptitude with an interest in understanding how manufacturing equipment and processes work.
• Ability to read, understand, and execute controlled manufacturing procedures and technical documentation.
• Experience working within a regulated quality system and following GMP requirements preferred.

Responsibilities

• Perform hands-on manufacturing of combination products per approved work instructions, SOPs, batch records, and quality system requirements.
• Develop strong technical expertise in manufacturing equipment and processes; perform setup, operation, cleaning, changeover, routine adjustment, and checks.
• Troubleshoot manufacturing equipment and process issues and coordinate resolution with management, Quality, vendors, or other resources.
• Serve as a primary contact with equipment vendors for troubleshooting, service, repair, and technical support.
• Perform or coordinate preventive maintenance, calibration, inspection, and servicing to maintain equipment in production-ready state.
• Maintain accurate equipment records including maintenance, calibration, service, and repair.
• Support installation, commissioning, qualification, and validation of new or modified equipment and processes.
• Support transfer of new products and processes from R&D into Manufacturing, including equipment readiness and operator training.
• Execute manufacturing, equipment qualification, and process validation protocols and assist with documentation.
• Support investigations, deviations, nonconformances, and corrective actions related to equipment or processes.

Skills

Mechanical aptitude

Technical aptitude

Troubleshooting

Documentation

Education

Bachelor's degree in Engineering/related field

Job description

Elutia is seeking a Manufacturing Technician, Equipment & Operations to join its growing Operations team. You will help establish manufacturing operations, prepare for a commercial launch, and support ongoing production of combination products with hands-on equipment work.

You will troubleshoot, calibrate, and maintain equipment, transfer processes from R&D to Manufacturing, and train new operators while helping ensure GMP compliance and quality throughout scale-up.