Validation Engineer – CSV

Pauwels Consulting; Geel; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking a CSV Engineer for a leading pharmaceutical client to support the validation of cGMP‑critical computerized systems. You will execute validation activities across URS, SIA, DQ, IQ, OQ, PQ, RV and TM, and develop validation protocols and reports to ensure ongoing compliance.

You bring 3+ years in CSV within pharmaceutical or GMP environments, with hands-on experience in validation documentation, software packages, and computerized systems.

Qualifications

• 3+ years of experience in CSV within pharmaceutical or GMP environments.
• Hands-on validation documentation experience and execution of URS, IQ, OQ, PQ.
• Experience with software packages and computerized systems.
• Proactive, professional, ownership attitude and independent work.
• Fluent in English and Dutch.

Responsabilités

• Execute CSV validation activities including URS, IQ, OQ, PQ, RV and TM.
• Develop and maintain validation documentation such as protocols and reports.
• Ensure validated status remains compliant with cGMP and regulatory standards.
• Validate software packages and interpret industry standards as required.
• Collaborate with project teams and QA to meet deliverables.

Connaissances

CSV Validation

Documentation

Communication

Independence

English fluency

Dutch fluency

Outils

Software packages

Computerized systems

Description du poste

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