Computerized Systems Validation

1 month ago


Montréal, Canada GenAIz Full time

Le Groupe Uni3T est une société informatique jeune et dynamique qui est active dans les secteurs des sciences de la vie et de l'industrie pharmaceutique. L'entreprise est née d'une volonté de réunir et d'unifier sous un même toit une expertise complète dans le domaine des sciences de la vie. Notre mission est d'améliorer l'accès aux soins et aux produits de santé en fournissant des services de consultation et des solutions technologiques aux entreprises des sciences de la vie.

Notre approche repose sur trois axes principaux. Toutes nos missions commencent par l'obtention d'une vision stratégique hautement alignée avec les besoins de nos clients. Nous travaillons avec nos clients sur la transformation de leurs processus afin de libérer le plein potentiel organisationnel. Enfin, notre équipe s'occupe du déploiement des technologies pour optimiser la chaîne de valeur de l'entreprise grâce à l'automatisation des processus clés, tout en assurant leur conformité réglementaire aux instances applicables.

Nous sommes à la recherche d'un talent pour se joindre à notre équipe de services professionnels. Ce professionnel travaillera au sein de notre équipe de spécialistes CSV sur les projets de validations de systèmes informatisés (CSV) dans un environnement réglementé.

**Responsabilités**:

- Effectuer des vérifications et des examens des documents de commissioning, qualification et validation pour les systèmes et les processus de nos clients
- Coordonner les projets CSV pour les logiciels et les systèmes automatisés
- Élaborer des stratégies et des plans de validation
- Coordonner les activités des différentes parties prenantes (département informatique, SMEs, utilisateurs finaux, unité qualité, fournisseurs)
- Effectuer une analyse des risques et définir le processus de qualification
- Rédiger et examiner les évaluations des risques et les scripts de test applicables conformément aux directives de conformité des GxP (BPF) et du CFR partie 11 et aux procédures de validation
- Élaborer et réviser des livrables du cycle de développement logiciel (SDLC), tels que : plans de validation, requis, spécifications, matrices de traçabilité, protocoles de test (IQ, OQ et PQ), rapports de qualification.
- Exécuter et réviser des protocoles de qualification pour assurer la conformité et le respect des lignes directrices applicables
- Participer à la résolution des déviations aux protocoles et procédures
- Examiner et modifier les procédures d'opération normalisées (SOPs)
- Communiquer les approches et les exigences du CSV pendant les réunions et les ateliers
- Développer et effectuer les formations clients

**Qualifications et compétences requises**:

- Maîtrise du français et de l'anglais écrits et parlés
- Solides compétences en communication et en relations interpersonnelles
- Intéressé à contribuer à l'entreprise tout en apprenant
- Proactif et organisé
- Soucieux du détail
- Fait preuve d'initiative
- Minimum de 4 ans d'expérience de travail dans les sciences de la vie ou l'industrie pharmaceutique
- Baccalauréat en informatique (sécurité, infrastructure, logiciel), génie (chimie, biomédical, biotechnologie, etc.) ou sciences de la vie (biochimie, chimie, pharmacie, etc.)

**Avantages**:

- Salaire de base compétitif + bonus (basé sur l'entreprise, l'équipe et les efforts individuels)
- Couverture d'assurance complète par RBC
- Cotisations REER
- Poste permanent à temps plein
- Remboursement du forfait téléphone mobile
- Culture d'entreprise dynamique avec des opportunités de développement de carrière
- Politique de travail à domicile (actuellement à temps plein, et une fois les restrictions levées, elle sera réévaluée avec flexibilité)
- Évenements d'entreprise réguliers.

**Exigences**:
- Peut être amené à se déplacer dans la grande région de Montréal jusqu'aux bureaux des clients.Uni3T Group is a young and dynamic IT company active in the life sciences and pharmaceutical industries. The company was born out of a desire to bring together and unify under one roof a complete expertise in the field of life sciences. Our mission is to improve access to health care and products by providing consulting services and technology solutions to life science companies.

Our approach is based on three main axes. Our missions begin with obtaining a strategic vision aligned with the needs of our customers. We work with our clients on transforming their processes to unlock the full organizational potential. Finally, our team takes care of the deployment of technologies to optimize the company's value chain through the automation of key processes, while enforcing regulatory compliance to all applicable regulations.

We are looking for a talent to join our professional services team. This professional will work with our team of CSV specialists on computerized systems validation (CSV) projects in a regulated environment.

**Responsi



  • Montréal, Canada Jubilant Pharma Holdings Inc. Full time

    **Spécialiste, Validation** Jubilant HollisterSiter, une filiale de Jubilant Pharma Holdings Inc., recrute actuellement pour un poste de Spécialiste, Validationpharmaceutique pour joindre notre équipe ! **Que pouvons-nous offrir?** Nous continuerons, avec le plus grand soin pour l'environnement et la société, à améliorer la valeur pour nos clients...


  • Montréal, Canada Centre de production de produits biologiques Inc Full time

    The Biologics Manufacturing Center ( BMC ) Inc. is a new biomanufacturing facility created in response to the pandemic. A not-for-profit organization, the BMC aims to better meet the biopharmaceutical needs of Canadians. The BMC helps support projects of public interest, actively contributes to the overall growth and resilience of the Canadian life sciences...


  • Montréal, Canada Leger Full time

    WHO WE ARE Founded in 1986, Leger empowers its clients to make better decisions by providing the highest-quality market research and data analytics in North America. Joining our company means joining a team of 600 passionate people who are committed to their work. We are the largest Canadian-owned market research and analytics company, with 8 offices across...


  • Montréal, QC, Canada Mannarino Systems & Software Inc. Full time

    MANNARINO Systems & Software Inc. is a leader in providing safety-critical systems & software engineering services to the aerospace, defense, space, simulation & power generation industries. We work with many of the top players within their industries giving our employees exposure to the most interesting and challenging development projects. The MANNARINO...

  • Validation Specialist

    1 month ago


    Montréal, QC, Canada Thorens Solutions Full time

    Validation Specialist Company name: Thorens Solutions – Headhunters Activity area : Technologies Salary : Based on experience Job type : Permanent - Full time , Hybrid work mode City : Montréal Company description Our client is a Quebec-based company offering unique and innovative technology. In full growth, our client specializes in the field...


  • Montréal, Canada MacLean Power Systems Full time

    Serve as primary liaison with customers to allow seamless business practices between company and internal and external customers. Handle customer service inquiries (e.g., distributor net pricing, lead time, freight estimate, etc.) and problems. Work with accounting to fix invoice discrepancies. Use computerized system for pricing, ordering, tracking,...


  • Montréal, QC, Canada SpaceBridge Inc. Full time

    We are currently seeking a Verification and Validation Specialist to join our team in Montreal, QC. In this position, the incumbent plays a crucial role in the product development process and contributes to bringing product quality upstream to ensure releases are meeting specifications. He or she is responsible for designing and executing test cases and...


  • Montréal, Canada Scotiabank Full time

    Requisition ID: 193053 Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture. **_ Purpose_** Validation Officer contributes to the overall success of the Dealer Finance Centre (DFC) in Canada ensuring specific individual goals, plans, initiatives are executed / delivered in support of the team’s business...


  • Montréal, Canada Scotiabank Full time

    Requisition ID: 193053 Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture. **_ Purpose_** Validation Officer contributes to the overall success of the Dealer Finance Centre (DFC) in Canada ensuring specific individual goals, plans, initiatives are executed / delivered in support of the team’s business...

  • Validation Engineer

    1 month ago


    Montréal, QC, Canada Thorens Solutions Full time

    Technologies Permanent - Full time , Hybrid work mode Our client is a Quebec-based company offering unique and innovative technology. In full growth, our client specializes in the field of new generations of wireless devices. Reporting to the Quality Assurance ValidationManager, work closely with firmware, hardware, application and ASIC teams in...


  • Montréal, Canada Monbel Technical Services Inc. Full time

    **Description de l'entreprise** Ingénierie, mise en service, validation, gestion de projet en industrie pharmaceutique **Description du poste** **Requirements**: - University or technical degree in engineering, science, pharmacy, or equivalent - or equivalent work experience - Up to one plus (1+) year of experience in pharmaceutical/biotechnology or...


  • Montréal, Canada Transat AT Full time

    **Job Description**: The business system analyst supports business teams in optimizing the use of "core business" systems and their integration into day-to-day activities. It plays a role in monitoring the integrity and validity of data all along the processing chain between the different systems. He supports business systems experts in the analyzes...


  • Montréal, QC, Canada ISC Applied Systems Corp ~ The Passenger Experience Full time

    ISC Applied Systems is a Canadian company specialized in the field of information and safety systems for passenger trains for more than forty (40) years. We develop fully integrated solutions to inform, monitor and communicate with our rail passengers worldwide. The systems engineer manages the evolution and integration of hardware and software parts of...


  • Montréal, Canada Noregon Systems Full time

    **_Outside Sales Representative_** **Role Summary** Outside Sales Representative As an Outside Sales Representative for Noregon Systems, you will prospect and cold-call sales leads in your territory, travel to prospective customer sites to deliver sales pitches and close deals. With Noregon Systems you will receive extensive training on product knowledge...


  • Montréal, Canada Aversan Full time

    As part of this Satellite Space & Ground Segments Systems Integration, Verification and Validation team, you will play a key role in creating and delivering engineering solutions to verify and validate payloads & satellites performance, Telecommand and Telemetry, data processing imagery, create value-added products and process orders from our customers in a...

  • System Administrator

    1 month ago


    Montréal, Canada CTConsultants Full time

    **CTC007560 - System Administrator**: **Secteur industriel: Bancaire/Banking**: **Type d'emploi: Contract**: **Durée: One year**: **Mode de travail: Mixed**: **Description**: Open hourly rate Bilingualism: French required, English not required Remote work: Hybrid required - 1 to 2 days/week in the Montreal office. Your knowledge of the technologies and...

  • Field Technician

    4 weeks ago


    Montréal, Canada Focal Systems Full time

    **Company Description** Focal Systems is the industry leader in retail AI solutions. We are a Silicon Valley-based startup that has more than doubled in size every year since our founding. Our mission is to automate and optimize brick and mortar retail using deep learning computer vision. Focal has been deployed at scale with the top retailers in the world....


  • Montréal, Canada McGill University Full time

    Please refer to the job aid for instructions on how to apply. Position Summary: Part of the Enrolment Services project team and responsible for the planning and development of policies as well as the implementation of information systems in response to needs of students and staff. Design and lead special IT projects, integrating new technologies and...


  • Montréal, Canada Opal-RT Full time

    English version will follow._ **OPAL-RT Technologies est à la recherche d'un stagiaire en validation et vérification (aéronautique).** **À propos d’OPAL-RT Technologies**: Imaginez travailler pour une entreprise qui compte parmi ses clients la NASA, Bombardier, ABB, EMBRAER, MIT, GE, Ford, GM, NREL et Hydro-Québec! OPAL-RT s’est donné comme...


  • montréal, Canada Recochem Inc. Full time

    Recochem is leading the way in offering global thermal management, emission control, vehicle care and household solutions that provide protection & safety to consumers and to the environment. Recochem excels at turning consumer insights into innovation while driving In-depth category expertise and building power brands that align to consumer preference. Our...