Validation Engineer – CSV
Il y a 3 heures
Antwerp, Flanders, Belgique
Pauwels Consulting
Temps plein
Gratuit avec email ou Google
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Gratuit avec email ou Google
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 HavesStrong interest and passion for CSV and validation processes.
Uitdagende projecten in lijn met jouw interesses en talentenPersoonlijke opvolging en open communicatie zowel voor als na indiensttredingMogelijkheid tot het volgen van extra opleidingenInspirerende netwerkevents en legendarische afterwork drinksSterk netwerk van toonaangevende klantenExpertise binnen IT, Engineering en Life SciencesEen vliegende start voor elke junior, verdere groei en kennisdeling voor onze seniorsChallenging projects based on your interests and skillsPersonal follow-up and clear, transparent communication both before and after commencement of employmentPossibility to follow extra trainingInspiring network events and legendary after work drinksStrong network of industry leading clientsExpertise within IT, Engineering and Life SciencesA flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employeesUn package salarial attractif avec de nombreux avantages extra-légauxUn suivi clair et personnalisé, une communication transparente autant durant la période de recrutement qu’une fois l’entrée effective en posteLa possibilité de suivre des formationsDivers événement vous permettant de développer votre réseau et des afterwork drinks légendairesUn réseau puissant de clients, leaders dans leur domaineUne expertise dans les domaines de l’informatique, de l’ingénierie et des sciences de la vieUn tremplin vers une évolution rapide pour les juniors et la possibilité de partager des connaissances acquises pour nos employés plus seniors•
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 HavesStrong interest and passion for CSV and validation processes.
Uitdagende projecten in lijn met jouw interesses en talentenPersoonlijke opvolging en open communicatie zowel voor als na indiensttredingMogelijkheid tot het volgen van extra opleidingenInspirerende netwerkevents en legendarische afterwork drinksSterk netwerk van toonaangevende klantenExpertise binnen IT, Engineering en Life SciencesEen vliegende start voor elke junior, verdere groei en kennisdeling voor onze seniorsChallenging projects based on your interests and skillsPersonal follow-up and clear, transparent communication both before and after commencement of employmentPossibility to follow extra trainingInspiring network events and legendary after work drinksStrong network of industry leading clientsExpertise within IT, Engineering and Life SciencesA flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employeesUn package salarial attractif avec de nombreux avantages extra-légauxUn suivi clair et personnalisé, une communication transparente autant durant la période de recrutement qu’une fois l’entrée effective en posteLa possibilité de suivre des formationsDivers événement vous permettant de développer votre réseau et des afterwork drinks légendairesUn réseau puissant de clients, leaders dans leur domaineUne expertise dans les domaines de l’informatique, de l’ingénierie et des sciences de la vieUn tremplin vers une évolution rapide pour les juniors et la possibilité de partager des connaissances acquises pour nos employés plus seniors•