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Senior Validation Manager
Senior Validation ManagerActalent • Calgary, Alberta, Canada
Senior Validation Manager

Senior Validation Manager

Actalent • Calgary, Alberta, Canada
16 hours ago
Job type
  • Full-time
Job description

Titre du poste : Gestionnaire Principal de Validation

Description du poste

Le gestionnaire principal de validation dirige les activités de validation sur les systèmes informatisés GxP et les solutions de fabrication numérique. Ce rôle est responsable de définir des stratégies de validation, de préparer et de réviser la documentation de validation, de coordonner les parties prenantes transversales et de garantir une livraison conforme et opportune sur plusieurs projets clients. Le gestionnaire principal de validation collabore étroitement avec les équipes Qualité, IT / OT, Automatisation et Fabrication pour s'assurer que la conception et les modifications du système respectent les attentes réglementaires et les pratiques de validation robustes.

Responsabilités

  • Diriger et exécuter les activités de validation de bout en bout pour les systèmes informatisés GxP et les plateformes de fabrication numérique.
  • Définir des stratégies de validation et diriger des ateliers.
  • Préparer et réviser la documentation (URS, FRS, évaluations des risques, scripts de test, rapports de validation).
  • Collaborer avec les équipes produit / ingénierie.
  • Assurer une conformité prête pour l'audit à travers plusieurs engagements.

Compétences Essentielles

  • Validation des systèmes informatisés (CSV)
  • Conformité GxP / GMP
  • Validation basée sur les risques
  • Rédaction technique et documentation
  • Validation SCADA / MES / Historian
  • Développement de stratégie de validation
  • Gestion des parties prenantes
  • Connaissance des systèmes IT / OT
  • Compétences Supplémentaires & qualifications

  • Exposition aux opérations de fabrication pharmaceutique
  • Connaissance des processus d'emballage, des utilités ou des processus de production
  • Familiarité avec les systèmes d'automatisation / OT
  • Environnement De Travail

    100 % à distance. Environnement collaboratif et transversal impliquant les équipes Qualité, IT / OT, ingénierie et fabrication. Le travail peut impliquer une collaboration à distance avec les sites clients, un travail en équipe basé sur des projets et la livraison de résultats de validation prêts pour l'audit dans un contexte réglementé.

    Type de poste & Emplacement

    Ce poste Contract to Hire est basé à Calgary, AB.

    Taux de rémunération & Avantages

    La fourchette salariale associée à ce poste est de $60.00 - $70.00 / hr.

    Type de milieu de travail

    Il s’agit d’un poste fully remote situé.

    Job Title : Senior Validation Manager

    Job Description

    The Senior Validation Manager leads validation activities across GxP computerized systems and digital manufacturing solutions. This role is responsible for defining validation strategies, preparing and reviewing validation documentation, coordinating cross-functional stakeholders, and ensuring compliant and timely delivery across multiple client projects. The Senior Validation Manager works closely with Quality, IT / OT, Automation, and Manufacturing teams to ensure system design and changes follow regulatory expectations and robust validation practices.

    Responsibilities

  • Lead and execute end-to-end validation activities for GxP computerized systems and digital manufacturing platforms.
  • Define validation strategies and lead workshops.
  • Prepare and review documentation (URS, FRS, risk assessments, test scripts, validation reports).
  • Collaborate with product / engineering teams.
  • Ensure audit-ready compliance across multiple engagements.
  • Essential Skills

  • Computer System Validation (CSV)
  • GxP / GMP Compliance
  • Risk-Based Validation
  • Documentation & Technical Writing
  • SCADA / MES / Historian Validation
  • Validation Strategy Development
  • Stakeholder Management
  • IT / OT Systems Knowledge
  • Additional Skills and Qualifications

  • Pharmaceutical manufacturing operations exposure
  • Knowledge of packaging, utilities, or shopfloor processes
  • Automation / OT system familiarity
  • Work Environment

    100% Remote. Collaborative, cross-functional environment involving Quality, IT / OT, engineering, and manufacturing teams. Work may involve remote collaboration with client sites, project-based teamwork, and delivering audit-ready validation outputs in a regulated context.

    Job Title : Senior Validation Manager

    Job Description

    The Senior Validation Manager leads validation activities across GxP computerized systems and digital manufacturing solutions. This role is responsible for defining validation strategies, preparing and reviewing validation documentation, coordinating cross-functional stakeholders, and ensuring compliant and timely delivery across multiple client projects. The Senior Validation Manager works closely with Quality, IT / OT, Automation, and Manufacturing teams to ensure system design and changes follow regulatory expectations and robust validation practices.

    Responsibilities

  • Lead and execute end-to-end validation activities for GxP computerized systems and digital manufacturing platforms.
  • Define validation strategies and lead workshops.
  • Prepare and review documentation (URS, FRS, risk assessments, test scripts, validation reports).
  • Collaborate with product / engineering teams.
  • Ensure audit-ready compliance across multiple engagements.
  • Essential Skills

  • Computer System Validation (CSV)
  • GxP / GMP Compliance
  • Risk-Based Validation
  • Documentation & Technical Writing
  • SCADA / MES / Historian Validation
  • Validation Strategy Development
  • Stakeholder Management
  • IT / OT Systems Knowledge
  • Additional Skills and Qualifications

  • Pharmaceutical manufacturing operations exposure
  • Knowledge of packaging, utilities, or shopfloor processes
  • Automation / OT system familiarity
  • Work Environment

    100% Remote. Collaborative, cross-functional environment involving Quality, IT / OT, engineering, and manufacturing teams. Work may involve remote collaboration with client sites, project-based teamwork, and delivering audit-ready validation outputs in a regulated context.

    Job Type & Location

    This is a Contract to Hire position based out of Calgary, AB.

    Pay and Benefits

    The pay range for this position is $60.00 - $70.00 / hr.

    Workplace Type

    This is a fully remote position.

    À propos d'Actalent :

    Actalent est un chef de file mondial des services d’ingénierie et de sciences et des solutions de talents. Nous aidons les entreprises visionnaires à faire progresser leurs initiatives en matière d’ingénierie et de science en leur donnant accès à des experts spécialisés qui favorisent la mise à l’échelle, l’innovation et la mise en marché rapide. Avec un réseau de près de 30 000 consultants et plus de 4 500 clients aux États-Unis, au Canada, en Asie et en Europe, Actalent est au service d’un grand nombre d’entreprises du classement Fortune 500.

    Actalent est un employeur souscrivant au principe de l’égalité des chances et accepte toutes les candidatures sans tenir compte de la race, du sexe, de l’âge, de la couleur, de la religion, des origines nationales, du statut d’ancien combattant, d’un handicap, de l’orientation sexuelle, de l’identité sexuelle, des renseignements génétiques ou de toute autre caractéristique protégée par la loi.

    Si vous souhaitez faire une demande d’accommodement raisonnable, tel que la modification ou l’ajustement du processus de demande d’emploi ou d’entrevue à cause d’un handicap, veuillez envoyer un courriel à

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