CSV / LIMS Specialist – Pharmaceutical Industry

2 days ago

Montreal, Quebec, Canada FORTIL Full time US$70,000 - US$100,000 per year

**English will follow**

Description du poste

Nous recherchons un Spécialiste CSV / LIMS expérimenté pour soutenir une initiative globale visant à optimiser les opérations de Contrôle Qualité (QC) et à digitaliser les processus de laboratoire au sein d'un environnement pharmaceutique.

Le candidat sélectionné jouera un rôle clé dans la mise en œuvre, la validation et la configuration des systèmes informatisés afin d'améliorer l'efficacité et la conformité réglementaire.

Responsabilités principales

  • Diriger et exécuter les activités de validation des systèmes informatisés (CSV) selon les exigences GMP.
  • Participer à la mise en œuvre du LIMS (LabVantage), à sa configuration et à la gestion des données maîtres.
  • Collaborer étroitement avec les équipes Projet, IT, QC et Qualité.
  • Assurer la cohérence entre les besoins opérationnels et les fonctionnalités du système.
  • Rédiger et réviser la documentation de validation (URS, FS, IQ/OQ/PQ, matrice de traçabilité).
  • Contribuer à l'amélioration continue des processus QC et des initiatives de data integrity.

Profil recherché

  • Minimum 5 ans d'expérience en CSV et/ou en mise en œuvre de LIMS dans l'industrie pharmaceutique.
  • Bonne connaissance des processus QC et flux de laboratoire.
  • Expérience avec LabVantage est un atout majeur.
  • Excellentes compétences en communication en français et en anglais.
  • Capacité à interagir avec des interlocuteurs techniques et métiers.
  • Sens du détail, rigueur et aptitude à évoluer dans un environnement projet dynamique.

English :

About the Role

We are seeking an experienced CSV / LIMS Specialist to support a global initiative focused on optimizing Quality Control (QC) operations and digitalizing laboratory processes within a major pharmaceutical environment. The selected candidate will play a key role in the implementation, validation, and configuration of computerized systems to enhance efficiency and compliance.

Key Responsibilities

  • Lead and execute Computer System Validation (CSV) activities for QC systems in compliance with GMP requirements.
  • Support LIMS (LabVantage) implementation, configuration, and Master Data setup.
  • Collaborate closely with cross-functional teams including Project Management, IT, QC, and Quality Assurance.
  • Ensure alignment between business needs and system capabilities through detailed requirement gathering and testing.
  • Prepare and review validation documentation (URS, FS, IQ/OQ/PQ, Traceability Matrix).
  • Contribute to the continuous improvement of QC processes and data integrity initiatives.

Qualifications

  • 5+ years of experience in CSV and/or LIMS implementation within the pharmaceutical industry.
  • Strong knowledge of QC processes and laboratory workflows.
  • Hands-on experience with LabVantage LIMS is a strong asset.
  • Excellent communication skills in English, French is a plus
  • Ability to interface effectively with both technical and operational stakeholders.
  • Detail-oriented, organized, and comfortable working in fast-paced project environments.

Job Type: Full-time

Pay: From $70,000.00 per year

Benefits:

  • Dental care
  • Extended health care
  • Life insurance
  • Paid time off

Work Location: In person

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