Validation Engineer

Physiol; Luik; Hybrid; EUR 55,000 - 70,000; Full time

Job summary

PhysIOL is seeking a highly skilled Validation Engineer to support the development, optimization, and validation of manufacturing processes in the medical device industry. The role involves working with cross-functional teams to ensure regulatory-compliant manufacturing with high quality and efficiency.

The ideal candidate will handle ISO 13485 validation, FDA regulations, and GMP, with expertise in CAD (SolidWorks) and ERP data management, delivering robust documentation and process

Qualifications

• Bachelor’s or Master’s degree in Mechanical or 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 GMP.

Responsibilities

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

Skills

Problem-solving

Team spirit

Communication

Project management

Fluent in French

Fluent in English

Education

Bachelor’s in Mechanical Engineering

Master’s in Manufacturing Engineering

Tools

SolidWorks

CAD Data Management

ERP Data Management

Job description

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), andspans 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