Validation Engineer

BVI Medical; Luik; On-site; 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

Purpose

We are seeking a highly skilled and motivated Validation Engineer to support the development, optimization, and validation of manufacturing processes in the medical device industry. This role involves working closely with cross-functional teams to ensure efficient, high-quality, and regulatory-compliant manufacturing processes. The ideal candidate will have experience in Validations under ISO 13485 and 21 CFR part 11.

Key Responsibilities

• Drive the validation of new production equipment, manufacturing processes, and CSV of computerized systems linked to production and quality control processes.
• Ensure test method validation TMV and confirm that methods meet quality requirements and deliver reproducible results.
• Prepare the related documentation and ensure its implementation within the Quality Control and Production departments.

Qualification

• Bachelor’s/Master's degree in Mechanical Engineering, Manufacturing Engineering, or related discipline.
• Minimum 3 years of experience.
• CAD expertise (Solidworks) and CAD Data Management.
• Master manufacturing Data Management inside ERP systems.
• Experience with ISO 13485, FDA regulations, and Good Manufacturing Practices (GMP).
• Problem-solving oriented.
• Team spirit, communication, and project management skills.
• Fluent in French & English.

Company

BVI® is refocusing the future of vision. As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries. We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

Learn more at www.bvimedical.com