Validation Engineer – Medical Device Process & CSV Expert

BVI Medical; Luik; Hybrid; EUR 55,000 - 85,000; Full time

Job summary

BVI Medical seeks a Validation Engineer to support validation of manufacturing processes and CSV of computerized systems in our medical device operations. You will collaborate with cross-functional teams to ensure compliant, high-quality production with ISO 13485 and GMP standards.

The ideal candidate has a Mechanical/Manufacturing Engineering background, 3+ years of experience, proficiency in Solidworks CAD, ERP data management, and fluent French and English for global collaboration.

Qualifications

• Bachelor’s or Master’s degree in Mechanical or Manufacturing Engineering or related field.
• Minimum 3 years of experience in validation/manufacturing in medical devices or similar.
• Experience with ISO 13485, FDA regulations and GMP.

Responsibilities

• Validate new production equipment and manufacturing processes, and CSV for computerized systems linked to production and QA processes.
• Verify test method validation (TMV) and ensure methods meet quality requirements with reproducible results.
• Prepare documentation and ensure its implementation within Quality Control and Production departments.

Skills

Problem-solving

Team spirit

Communication

Project management

Education

Bachelor’s/Master's degree in Mechanical or Manufacturing Engineering

Tools

Solidworks

CAD Data Management

ERP Master Data Management

Job description

BVI Medical seeks a Validation Engineer to support validation of manufacturing processes and CSV of computerized systems in our medical device operations. You will collaborate with cross-functional teams to ensure compliant, high-quality production with ISO 13485 and GMP standards.

The ideal candidate has a Mechanical/Manufacturing Engineering background, 3+ years of experience, proficiency in Solidworks CAD, ERP data management, and fluent French and English for global collaboration.