On behalf of our client, we are seeking a dedicated Validation & Automation Quality Specialist to oversee and ensure the validated status of systems, methods, and processes throughout the product lifecycle.
In this position, you will:
* Lead and coordinate all validation activities to ensure they align with regulatory standards.
* Review and approve documentation for systems, methods, and processes
* Participate in product development and continuous improvement initiatives, particularly involving IVD software and automated systems
Company Description:
Our client is an innovative and internationally active life sciences company located in the greater Flemish region. With a strong focus on advanced diagnostic solutions, the organization supports healthcare professionals worldwide by enabling fast and accurate disease diagnosis. Employees benefit from a collaborative, cross-functional work environment that encourages knowledge sharing, autonomy, and personal growth. This dynamic company is part of a global group with operations all over the world.
Essential Requirements:
* Master’s degree in Pharmacy, (Bio-)Engineering, Chemistry, or Biology
* Minimum 5 years of experience in a GxP-regulated environment, preferably in QA within pharma, biotech, or medical devices
* At least 5 years of hands-on validation experience; process validation is a strong plus
* Strong knowledge of global validation requirements, design controls, and software-related regulatory standards
* Proficient in Dutch and English with excellent communication and presentation skills
* Solid understanding of production, quality control processes, utilities, and project management
* Highly organized, practical, and team-oriented, with a proactive and transparent working style
Desirable Requirements:
* Experience in process validation and contract manufacturing environments
* Familiarity with IVD product development and diagnostic testing solutions
Additional insights:
This is a unique opportunity to contribute to the future of diagnostics within a science-driven organization that values both technical expertise and cross-functional teamwork. You will have the autonomy to shape your role while collaborating with professionals across various departments, from R&D to commercial operations. This position offers the right candidate an intellectually stimulating work environment with significant room for professional development.
For more information please don’t hesitate to get in touch with Cristina Ruiz Senac at c.ruiz@panda-int.com