Quality Engineer Validation & Automation

About the position

As a Quality Engineer, specializing in Validation and Automation, you will play an important role in ensuring the validated status of all systems, methods, processes at any time during the product lifecycle. Your responsibilities include:

• organizing and managing all validation activities to meet regulatory standards and regulations;
• reviewing and approving validation documentation (systems, methods & processes) to ensure compliance with all applicable standards and regulations;
• participating in development and improvement projects to ensure that IVD software and automation systems meet customer expectations, business and regulatory requirements.

Your Profile

• Education: Master’s degree in Pharmacy, (Bio)-Engineering/Chemistry or Biology.
• Experience: at least 5 years in a GxP environment, preferably in QA within the pharma, biotech or medical device industry, minimum 5 years specifically in validation. Process validation experience is a plus.
• Expertise: comprehensive knowledge of global validation requirements, design control standards and specific software related regulatory requirements.
• Technical skills: familiar with production, QC processes, utilities and project management.
• Communication: strong presentation skills, with fluency in Dutch and English.
• Personal qualities: you have a straightforward approach and work organised, accurate, practical with a strong ream-oriented mindset.

Our Offer

By joining Fujirebio you contribute to a better healthcare in a company where different cultures meet each other which makes our jobs challenging and stimulating.

Our employees appreciate their rich job content and the great deal of independence within their job.

In an open, informal and dynamic work environment you will be collaborating with our scientific, commercial, operational and supportive teams. To support this collaboration and to support personal growth of all team members we offer our employees the opportunity to develop their knowledge, skills and talents.

 
About us

Our committed and engaged employees make that Fujirebio Europe (previously Innogenetics) provides innovative IVD solutions for healthcare all over the world.

Our products and services allow doctors to make fast and accurate diagnosis in different disease fields like infectious diseases and neurological disorders. Based upon our high-quality testing, appropriate treatment can be started quickly. We strive at being the best in each disease field in offering the best and unique diagnostic solution.

We develop and manufacture diagnostic tests at our site in Ghent, as well as in Tokyo, after which they are sold worldwide by our commercial teams to hospitals and clinical labs.

Furthermore, we use our advanced experience in development and manufacturing of Diagnostic solutions and our high-quality standards for contract manufacturing projects with third parties.

Fujirebio Europe belongs to an international group (H.U.Group) with branches and colleagues in Asia, Europe and the USA. We currently employ 145 people at the headquarters in Ghent and 50 people in our European affiliates.