Computer System Validation

Vor 3 Tagen


Lausanne, Schweiz Expleo Vollzeit
Overview

Expleo Life Sciences Switzerland spécialisé dans les métiers de l'ingénierie en life sciences (industrie pharmaceutique, biotechnologie, chimie fine et dispositifs médicaux), renforce ses équipes en Suisse et recrute un(e) Ingénieur(e) Computer System Validation (CSV) Specialist.

Être consultant/e chez Expleo Life Sciences Switzerland, c’est :

  • Accomplir des défis pour participer au développement de l’entreprise
  • Intégrer une équipe dynamique
  • Avoir un accompagnement humain à chaque mission et un suivi performant de votre carrière
  • Réaliser des activités mensuelles afin d’établir de nouveaux contacts
  • Participer au sein de l’entreprise à des événements spéciaux dédiés
  • Pouvoir réaliser des formations pour développer ses capacités professionnelles

Contexte et responsabilités du poste

Intégré(e) au sein des équipes de notre client, vous participerez aux différentes phases des projets afin de concevoir ou améliorer les opérations actuelles, et de déterminer des processus plus efficaces.

  • Création, rédaction, mise à jour des documents de qualification selon procédures en vigueur. Cela comprend : Les Plans de qualification / validation (VP) ; Protocoles / rapports de qualification (IQ, OQ, PQ) ; Matrices de traçabilité (TM)
  • Organiser et mener l’exécution de tests de qualification IQ/OQ/PQ.
  • Collaboration avec les services globaux et les autres sites participants aux qualifications initiales et les différentes modifications.
  • Rédaction et suivi des déviations selon le système en place lors des qualifications initiales
  • Assurer le maintien des indicateurs de performance du service
  • Participation active à l’amélioration des processus de qualification en place

Expériences

Vous disposez d’un esprit d’analyse des opérations et d’une capacité à résoudre des problèmes. De solides compétences en direction et en participation aux discussions de projets sont essentiels.

Les requis pour accéder au poste sont les suivants:

  • Au moins 3 ans d’expérience dans un environnement pharmaceutique / biotechnologies (environnement GMP)
  • Expériences en qualification
  • CSV/ Data integrity (21 CFR part 11)
  • Systèmes Informatisés/ Automatisés (SI/SA) : Discoverant (Monitoring Process), Manufacturing Execution System (MES Batch record), Digital Plant Transformation (DPT)
  • Aisance avec les outils bureautiques, notamment Word, Excel et PowerPoint
  • Très bon niveau d’anglais/français (oral et écrit)

N'hésitez pas à postuler directement : constance.crinon@explegroup.com

Essential skills

La localisation des postes n’est qu’indicative, une mobilité géographique sur le territoire national peut être requise si la mission client le nécessite ou si une nouvelle mission est demandée.

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