Computer System Validation (CSV) Engineer

Our client, a leading organization in the life sciences sector, is seeking a professional to support computer system validation activities. The role focuses on ensuring that computerized and automated systems in GxP-regulated environments are fit for purpose and comply with both regulatory requirements and internal standards.

• Draft comprehensive validation documentation for computerized systems.
• Perform Computer System Validation (CSV) activities for DCS and PLC systems and interfaces.
• Implement Design Qualification (DQ) protocols for automated systems.
• Execute validation testing including IQ, OQ, and PQ phases.
• Identify and mitigate compliance risks throughout the project.
• Coordinate with multidisciplinary teams including engineering and quality departments.

• You have 3+ years of experience in validation activities with a focus on Computer System Validation (CSV).
• You bring experience in validating automated systems and knowledge of Data Integrity principles.
• You possess expertise in compliance requirements such as 21 CFR Part 11, EU Annex 11, and GAMP 5.
• You have experience with quality assurance processes including change control and deviation management within a GMP environment.
• You're analytical and structured with strong technical documentation and communication skills.
• You are fluent in English.

Nice to Haves

• Knowledge of process automation systems such as Emerson DeltaV or Siemens PLC/HMI.
• Experience with Equipment Validation, Kneat, and risk-based validation approaches.
• Basic knowledge of USP and DSP 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