Equipment & Validation Specialist

LaCAR MDX Technologies; Luik; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

Flexible working hours

Salary package

Permanent contract (38h/week)

HQ Belgium location with terrace

Free fruits & Soup Tuesdays

Résumé du poste

LaCAR is a fast-growing biotech company developing, producing, and commercializing CE-IVD diagnostic kits for (pharmaco) genetics and newborn screening. Our headquarters are located in the Liège Science Park (Belgium), and we serve customers worldwide.

We are looking for an Equipment and Validation Specialist to ensure equipment performance, compliance, and reliability in manufacturing and QC. You will lead qualification activities, coordinate maintenance, and support audits in a regulated

Qualifications

• Bachelor’s or Master’s degree in a technical field
• Experience with equipment qualification, validation, maintenance, calibration, or metrology in a regulated environment
• Knowledge of IQ/OQ/PQ and related documentation
• Understanding of IVDR or GMP and data integrity
• Experience coordinating external service providers is a plus
• Strong analytical, troubleshooting, and problem-solving skills
• Highly organized with ability to manage multiple priorities
• Autonomous, proactive, and accountable with ownership
• Excellent collaboration and communication
• Advanced English (min B2) for professional communication

Responsabilités

• Lead qualification activities for new and existing equipment (IQ/OQ/PQ)
• Develop and maintain qualification plans and requalification schedules
• Coordinate preventive maintenance programs to maximize reliability
• Troubleshoot equipment issues and manage repairs
• Organize calibration, verification, and metrology activities
• Maintain accurate equipment documentation and records
• Support change controls, deviations, CAPAs, risk assessments, and improvements
• Collaborate with Production, QC, QA and external partners
• Participate in internal, customer, and regulatory audits
• Contribute to equipment lifecycle management and continuous improvement

Connaissances

Analytical skills

Troubleshooting

Problem solving

Organization

Communication

Team player

Autonomous

Formation

Bachelor’s or Master’s degree in Engineering or related technical field

Outils

Microsoft Office

CMMS / Computerized equipment management systems

Description du poste

Equipment & Validation Specialist (Biotech Diagnostics)

Join a fast-growing European biotech Company!

Want to join a growing company in the biotech industry?

Are you passionate about technology, equipment reliability, and continuous improvement?

Do you enjoy combining hands-on technical activities with project coordination in a regulated environment?

Would you like to contribute to innovative diagnostic solutions that improve patients' lives worldwide?

At LaCAR, we are advancing health and improving lives through the development, production, and commercialization of innovative CE-IVD diagnostic solutions.

As part of our continued growth, we are looking for an Equipment and Validation Specialist to ensure the performance, compliance, and reliability of the equipment supporting our Manufacturing and Quality Control activities.

You will play a key role in managing equipment throughout their lifecycle, from qualification and maintenance to calibration, troubleshooting, and continuous improvement.

Your Key Responsibilities:

• Lead qualification activities for new and existing equipment, including planning, protocol development, execution, deviation management, and final reporting (IQ/OQ/PQ)
• Develop and maintain qualification and requalification plans to ensure timely execution and regulatory compliance
• Coordinate and oversee preventive maintenance programs to maximize equipment reliability and availability
• Troubleshoot equipment issues, manage repair activities, and perform root cause investigations to minimize downtime
• Organize and supervise calibration, verification, and metrology activities in collaboration with internal stakeholders and external service providers
• Maintain accurate and compliant equipment documentation, including qualification records, calibration certificates, maintenance logs, and technical files
• Support change controls, deviations, CAPAs, risk assessments, and continuous improvement initiatives related to equipment and utilities
• Collaborate closely with Production, QC, QA, and external partners to ensure equipment performance and regulatory compliance
• Participate in internal audits, customer audits, and regulatory inspections by providing technical expertise and supporting documentation
• Contribute to the continuous enhancement of equipment lifecycle management, reliability, and operational efficiency

Who Are We?

LaCAR is a fast-growing biotech company developing, producing, and commercializing CE-IVD diagnostic kits for (pharmaco) genetics and newborn screening. Our headquarters are located in the Liège Science Park (Belgium), and we serve customers worldwide.

Who Are We Looking For?

• You hold a Bachelor’s or Master’s degree in Engineering, Industrial Technology, Life Sciences, Automation, or a related technical field
• You have experience in equipment qualification, validation, maintenance, calibration, or metrology within a regulated environment, ideally in IVD, pharmaceutical, biotechnology, medical devices, or a similar industry
• You have a good understanding of equipment qualification methodologies, including IQ/OQ/PQ, and are comfortable preparing technical documentation such as protocols, reports, procedures, and equipment records
• You have a solid understanding of IVDR or GMP requirements and data integrity principles
• Experience coordinating external service providers, maintenance activities, or equipment management is a plus
• You have strong analytical, troubleshooting, and problem-solving skills and enjoy finding practical solutions to technical challenges
• You are highly organized and able to manage multiple priorities while maintaining accuracy and attention to detail
• You are autonomous, proactive, and accountable, with a strong sense of ownership and responsibility
• You have a quality- and compliance-driven mindset and are committed to continuous improvement
• You are a team player with excellent communication and collaboration skills.
• You are proficient with Microsoft Office and computerized equipment management systems
• Advanced level of English (at least B2) for daily professional communication

Why Join Us?

• Become part of an innovative and fast-growing biotech company making a real impact on healthcare
• Develop your expertise through comprehensive onboarding and continuous learning opportunities
• Take ownership of a critical role combining technical challenges, project coordination, and continuous improvement
• Work in an international environment alongside passionate and talented colleagues
• Join a collaborative, agile, and people-oriented culture where your contribution truly matters
• Fun team events & great atmosphere
• Flexible working hours & salary package
• Permanent contract (38h/week)
• Inspiring work environment (HQ Belgium)– Overlooking the woods of Sart-Tilman, with a south-facing terrace for afterwork events
• Free fruits & Free-Soup-Tuesdays