Validation Engineer – CSV

Our client, a leading pharmaceutical company, is seeking a CSV Engineer to support the validation of cGMP-critical computerized systems. The role focuses on ensuring systems remain compliant with applicable regulatory and quality requirements through hands-on validation activities.

• Execute validation activities including URS, SIA, DQ, IQ, OQ, PQ, RV, and TM.
• Develop and maintain validation documentation such as protocols and reports for computerized systems.
• Ensure the validated status of systems remains compliant with cGMP and regulatory standards.
• Perform validation of software packages where industry standards require interpretation and specific application.
• Provide input into change assessments to determine potential impacts on validated status.
• Investigate and troubleshoot validation-related issues within the project environment.
• Collaborate with project teams and quality assurance stakeholders to meet deliverables.

• You have 3+ years of experience in CSV (Computer System Validation) within a pharmaceutical or GMP environment.
• You bring expertise in validation documentation and the execution of URS, IQ, OQ, and PQ protocols.
• You possess relevant project experience working with software packages and computerized systems.
• You're a proactive and professional individual capable of taking ownership and working independently.
• You possess strong communication skills and the ability to adapt quickly to new project environments.
• You are fluent in English and Dutch.

Nice to Haves

• Strong interest and passion for CSV and validation processes.

• Uitdagende projecten in lijn met jouw interesses en talenten
• Persoonlijke opvolging en open communicatie zowel voor als na indiensttreding
• Mogelijkheid tot het volgen van extra opleidingen
• Inspirerende netwerkevents en legendarische afterwork drinks
• Sterk netwerk van toonaangevende klanten
• Expertise binnen IT, Engineering en Life Sciences
• Een vliegende start voor elke junior, verdere groei en kennisdeling voor onze seniors

• Challenging projects based on your interests and skills
• Personal follow-up and clear, transparent communication both before and after commencement of employment
• Possibility to follow extra training
• Inspiring network events and legendary after work drinks
• Strong network of industry leading clients
• Expertise within IT, Engineering and Life Sciences
• A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

• Un package salarial attractif avec de nombreux avantages extra-légaux
• Un suivi clair et personnalisé, une communication transparente autant durant la période de recrutement qu’une fois l’entrée effective en poste
• La possibilité de suivre des formations
• Divers événement vous permettant de développer votre réseau et des afterwork drinks légendaires
• Un réseau puissant de clients, leaders dans leur domaine
• Une expertise dans les domaines de l’informatique, de l’ingénierie et des sciences de la vie
• Un tremplin vers une évolution rapide pour les juniors et la possibilité de partager des connaissances acquises pour nos employés plus seniors