Microbiology Lab Engineer — Quality & Regulatory

Terumo Europe NV; Town of Belgium (WI); Hybrid; USD 85,000 - 125,000; Full time

Job summary

Terumo seeks a Lab Engineer Microbiology to develop, validate, implement, and oversee biological testing programs ensuring quality, safety, and regulatory compliance of medical products.

You will lead cross-functional collaborations with Product Engineering, Chemical Laboratory, Quality, and Regulatory Affairs, drive method improvements, address CAPA findings, and support audits and inspections while upholding a culture of integrity and excellence.

Qualifications

• Master's degree or equivalent experience in a regulated lab environment.
• Proven expertise in microbiological testing, validation, troubleshooting.
• Knowledge of ISO standards, pharmacopoeia requirements, and quality systems.

Responsibilities

• Lead and coordinate development, validation, implementation, and lifecycle management of biological and microbiological test methods, ensuring compliance with internal quality requirements and international standards
• Drive continuous improvement of testing capabilities by enhancing methodologies, increasing efficiency, optimising laboratory processes, and supporting high service levels across teams
• Coordinate biological endpoint testing with Product Engineering, Chemical Laboratory, Quality, and Regulatory Affairs to support risk assessments
• Investigate deviations, implement corrective and preventive actions (CAPA), and collaborate with stakeholders for timely resolution
• Serve as SME and point of contact for audits and regulatory inspections, representing the organisation
• Assess and support implementation of new regulatory requirements across manufacturing sites to ensure consistency
• Contribute to cross-functional improvement initiatives, product development, and strategic projects
• Promote quality culture, collaboration, continuous learning, and operational excellence

Skills

Biological testing

Microbiology

Data analysis

Regulatory knowledge

Communication

Education

Master's degree in Biology, Microbiology, Life Sciences, or related scientific discipline

Job description

Terumo seeks a Lab Engineer Microbiology to develop, validate, implement, and oversee biological testing programs ensuring quality, safety, and regulatory compliance of medical products.

You will lead cross-functional collaborations with Product Engineering, Chemical Laboratory, Quality, and Regulatory Affairs, drive method improvements, address CAPA findings, and support audits and inspections while upholding a culture of integrity and excellence.