Manufacturing Technician

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

The Manufacturing Technician, Equipment & Operations is a hands‑on member of Elutia's Operations team responsible for supporting the start‑up, scale‑up, and ongoing manufacture of combination products. The position will initially focus on establishing manufacturing operations and preparing for the commercial launch of a new product and will transition into supporting routine commercial manufacturing as production scales.

This individual will perform manufacturing activities while developing deep technical expertise in the equipment and processes used to manufacture Elutia products. The role will serve as a key resource for equipment setup, operation, troubleshooting, maintenance, and continuous improvement and will coordinate with equipment vendors and other technical resources when additional support is required.

The position works cross‑functionally with Operations, R&D, Quality, and external vendors to ensure manufacturing processes and equipment are safe, reliable, compliant, and ready to support commercial production.

How You'll Contribute:

Perform hands‑on manufacturing of combination products in accordance with approved work instructions, SOPs, batch records, and quality system requirements.

Develop strong technical expertise in manufacturing equipment and processes. Perform equipment setup, operation, cleaning, changeover, routine adjustment, and operational checks required to support manufacturing.

Troubleshoot manufacturing equipment and process issues, identify potential causes, and coordinate resolution with management, Quality, equipment manufacturers, service providers, or other technical resources as needed.

Serve as a primary point of contact with equipment vendors for troubleshooting, service, repair, technical support, and equipment‑related questions.

Perform or coordinate preventive maintenance, calibration, inspection, and servicing activities to maintain equipment in a safe, qualified, and production‑ready state.

Maintain accurate and complete equipment records, including maintenance, calibration, service, repair, and equipment‑use documentation.

Support installation, commissioning, qualification, and validation of new or modified manufacturing equipment and processes.

Support transfer of new products and processes from R&D into Manufacturing, including equipment readiness, manufacturing flow, work instructions, process development, and operator training.

Execute manufacturing, equipment qualification, and process validation protocols and assist with preparation and completion of associated documentation.

Support manufacturing investigations, deviations, nonconformances, and corrective actions related to equipment or manufacturing processes.

Identify and implement opportunities to improve equipment reliability, process capability, manufacturing efficiency, safety, and workflow.

Prepare and revise manufacturing documentation, including SOPs, work instructions, equipment procedures, forms, and change requests.

Support development of manufacturing processes and infrastructure as the organization transitions from product development and launch readiness into routine commercial production.

Train other manufacturing personnel on equipment operation, manufacturing procedures, and equipment best practices as the manufacturing organization grows.

Work effectively in a growing, dynamic environment where responsibilities may evolve as manufacturing capabilities and commercial production expand.

Perform other Operations and manufacturing activities as needed to support business and production requirements.

What You'll Bring:

• Bachelor's degree in Engineering, Engineering Technology, Manufacturing, Life Sciences, or a related technical field required.

2-4 years of experience in manufacturing, operations, engineering support, or a related technical environment.

Experience in medical device, pharmaceutical, biotechnology, combination product, or another regulated manufacturing environment preferred.

Strong mechanical and technical aptitude with an interest in understanding how manufacturing equipment and processes work.

Demonstrated ability to operate and troubleshoot manufacturing equipment and systematically work through technical problems.

Ability to recognize when additional technical expertise is required and effectively coordinate support from equipment vendors, engineers, service providers, or other resources.

Ability to read, understand, and execute controlled manufacturing procedures and technical documentation.

Experience working within a regulated quality system and following Good Manufacturing Practice (GMP) requirements preferred.

Strong problem‑solving skills and practical judgment.

High attention to detail and commitment to accurate documentation.

Strong written and verbal communication skills.

Ability to manage multiple priorities and operate effectively in a fast‑paced, growing manufacturing environment.

Guided by purpose, trust, and inclusion, Elutia is proud to be an equal opportunity employer.

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