Process Quality Engineer: Scale-Up & Tech Transfer

Elutia; Gaithersburg (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

Elutia is seeking a hands-on Process Quality Engineer to drive quality activities supporting transfer, scale-up, and commercial manufacture of drug-eluting biological products in a fast-paced environment.

This role partners with Operations and R&D to translate development processes into robust, controlled manufacturing workflows. It covers process characterization, studies, deviations, CAPA, and audits to ensure compliant operations.

Qualifications

• Bachelor’s degree in engineering, science, or related technical discipline.
• 5+ years of quality/process/manufacturing engineering in regulated field.
• Experience supporting manufacturing process development, scale-up, characterization, or validation.
• Experience with change control, investigations, nonconformances, CAPA, and risk management.
• Working knowledge of FDA Quality System requirements/QMSR and ISO 13485.
• Strong problem-solving skills and ability to drive work in fast-paced environment with competing priorities.

Responsibilities

• Partner with Operations and R&D to translate development processes into scalable manufacturing.
• Support process characterization, studies, deviations, CAPA, and audits to ensure compliant operations.
• Lead change controls, investigations, CAPA, and root-cause investigations.
• Support Quality Management System processes including change control, CAPA, nonconformance and deviation management, document control, training, supplier quality, validation, and risk management.
• Assist with internal and external audits, including preparation, response development, and follow-up actions.
• Provide hands-on quality support on the manufacturing floor during scale-up, process changes, validation activities, investigations, and troubleshooting.

Skills

Quality Engineering

Process Engineering

Manufacturing Engineering

Risk management

Problem solving

QMSR knowledge

Education

Bachelor's degree in engineering/science

Tools

IQ/OQ/PQ

Job description

Elutia is seeking a hands-on Process Quality Engineer to drive quality activities supporting transfer, scale-up, and commercial manufacture of drug-eluting biological products in a fast-paced environment.

This role partners with Operations and R&D to translate development processes into robust, controlled manufacturing workflows. It covers process characterization, studies, deviations, CAPA, and audits to ensure compliant operations.