About us
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At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced Senior CSV Engineer.
Job description
- Minimum 5 années d’expérience à un poste similaire
- Connaissance de l’environnement de production Pharma et Idéalement MedTech
- Bonnes connaissances des GxP
- Bonnes connaissances du référentiel GAMP 5
- Connaissance réglementaire : ISO 13485, IEC 62 304, ISO 2859-1, 21 CFR Part 11, Part 820 serait un plus
- Langues: FRANCAIS et ANGLAIS COURANT, L’Allemand serait un avantage certain
Your profile
- Piloter les activités liées à la CSV
- Définir le Plan de validation
- Réaliser l’analyse de risque
- Etablir la matrice de traçabilité
- Rédiger et exécuter les tests de qualification (QI, QO, QP)
- Capitaliser sur les tests fournisseurs (FAT / SAT)
- Faire monter en compétences les fournisseurs du software et Hardware sur les tâches de CSV qu’ils doivent réaliser
- Auditer les fournisseurs et interne
- Etablir les rapports de validation finaux
Benefits:
- Between 30% and 70% remote work in agreement with your manager and client needs (40% for cross boarders due to tax regulation)
- Options to order ergonomically proven equipment (monitor & chair) for your home-office premises
- Support for trainings, formation upon agreement with the manager
- Contribution on gym subscription
- Trust-based managerial culture
- Team rituals and get togethers
We look forward to receiving your application. Capgemini Engineering only accepts direct applications (no recruitment agencies). Due to Swiss regulations we only consider Swiss or EU/EFTA applicants or applicants with a valid work permit.
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