Computerized System Validation Engineer

vor 2 Monaten


Lausanne greater area, Schweiz Capgemini Suisse SA Vollzeit
About Us

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 (Computerized System Validation) CSV Engineer.


Job description
•    Develop and execute CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for 
     computerized systems.
•    Maintain comprehensive documentation for all CSV activities, ensuring adherence to regulatory standards and internal quality procedures.
•    Collaborate with quality assurance teams to support regulatory inspections and audits.
•    Implement and manage change control processes for computerized systems, conducting impact assessments for proposed changes.
•    Ensure that changes to systems do not compromise data integrity or regulatory compliance.
•    Support the full system lifecycle, from system design and implementation to periodic reviews and retirement.

 

Your Profile
•    Bachelor's or Master's degree in relevant field, e.g., Computer Science, Engineering.
•    Experience in CSV within the life science industry.
•    Familiarity with regulatory requirements, including FDA, EMA, and other relevant guidelines.
•    Strong understanding of operational processes in biopharmaceutical manufacturing.
•    Excellent communication in English and French


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.
 



  • Lausanne greater area, Schweiz Capgemini Suisse SA Vollzeit

    About Us 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 (Computerized System...


  • Lausanne, Schweiz Capgemini Vollzeit

    About Us 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 (Computerized...


  • Lausanne, Schweiz Capgemini Vollzeit

    About Us 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 (Computerized System...


  • Lausanne, Schweiz Proclinical Vollzeit

    Proclinical are recruiting a Computerised Systems Validation Lead for a pharmaceutical corporation. This role is on a permanent basis and is located in Lausanne. **Responsibilities**: - You will be a part of CSLC/CSV Project Teams for specific computerised systems or appoint it to a CSV qualified individual. - Maintain oversight on DPI computerised system...


  • Lausanne, Schweiz Axepta SA Vollzeit

    QA Validation EngineerOur client, a medical devices company and one of the leaders in its field, is currently looking for a QA Validation Engineer. YOUR RESPONSIBILITIES:  - Support qualification and validation activities in compliance with FDA and GMP requirements (production equipment) - Participate in the review of technical and...

  • QA Validation Engineer

    vor 2 Wochen


    Lausanne, Schweiz Axepta SA Vollzeit

    QA Validation EngineerOur client, a medical devices company and one of the leaders in its field, is currently looking for a QA Validation Engineer. YOUR RESPONSIBILITIES:  - Support qualification and validation activities in compliance with FDA and GMP requirements (production equipment) - Participate in the review of technical and...

  • QA Validation Engineer

    vor 2 Monaten


    Lausanne, Schweiz Axepta SA Vollzeit

    Our client, a medical devices company and one of the leaders in its field, is currently looking for a QA Validation Engineer. YOUR RESPONSIBILITIES:  - Support qualification and validation activities in compliance with FDA and GMP requirements (production equipment) - Participate in the review of technical and quality documentation for all departments...

  • QA Validation Engineer

    vor 2 Wochen


    Lausanne, Schweiz Axepta SA Vollzeit

    Our client, a medical devices company and one of the leaders in its field, is currently looking for a QA Validation Engineer. YOUR RESPONSIBILITIES:  - Support qualification and validation activities in compliance with FDA and GMP requirements (production equipment) - Participate in the review of technical and quality documentation for all departments...

  • CQV Engineer

    vor 2 Monaten


    Zurich greater area, Schweiz Capgemini Suisse SA Vollzeit

    About Us 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 CQV Engineer.   Job...

  • CQV Engineer

    vor 2 Wochen


    Zurich greater area, Schweiz Capgemini Suisse SA Vollzeit

    About Us 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 CQV Engineer.   Job...

  • Csv Expert

    vor 1 Woche


    Lausanne, Schweiz ALTOGEN AG Vollzeit

    **ALTOGEN **is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to expert...


  • Lausanne, Schweiz AXEPTA SA Vollzeit

    Technicien Qualification et Validation – 1 anRESPONSABILITES :Gestion documentaire : plan de validations, protocoles, rapports et traçabilitéQualification et validation des équipements, locaux, utilités et système informatiséSuivi des écartsCréation des URS, FAT/SAT, et analyses de risquesRevue...

  • CQV Engineer

    vor 4 Wochen


    Bern greater area, Schweiz Capgemini Suisse SA Vollzeit

    About Us 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 CQV Engineer.   Job...


  • Lausanne, Schweiz EURHASI Vollzeit

    EURHASI is recruiting for its client a CSV Engineer French-EnglishOur client is a Swiss consulting company composed of a passionate team of experienced Life Sciences professionals.Since 2014 our client delivers outstanding industry’s expertise and support to their clients in the complete product life cycle such as: R&D, Engineering and Construction,...


  • Lausanne, Schweiz EURHASI Vollzeit

    Job DescriptionEURHASI is recruiting for its client a CSV Engineer French-EnglishOur client is a Swiss consulting company composed of a passionate team of experienced Life Sciences professionals.Since 2014 our client delivers outstanding industry’s expertise and support to their clients in the complete product life cycle such as: R&D, Engineering and...


  • Lausanne, Schweiz Axepta SA Vollzeit

    Senior engineer lab systemOur client, a global and growing biotechnology company with a strong reputation is looking for a Senior Lab System Engineer to join his team in Vaud canton.This role is administrator of LIMS QC system and complex laboratory equipment. YOUR RESPONSIBILITIES :Serve as the primary contact for LIMS/ELN and complex lab...

  • Validation Engineer

    vor 2 Monaten


    Lausanne, Schweiz Catherine BIAUDET Consultant indépendant en recrutement pour Hunteed Vollzeit

    Vous assumerez la validation de nos systèmes d’assemblage, selon les objectifs convenus avec nos partenaires (délais, qualité). Pour cela, vous identifierez les problèmes techniques, rechercherez des solutions et les communiquerez aux Teams de Projets. Être le point de contact central entre les partenaires et l’équipe de projet en interne pour...

  • Validation Engineer

    vor 2 Wochen


    Lausanne, Schweiz Catherine BIAUDET Consultant indépendant en recrutement pour Hunteed Vollzeit

    Vous assumerez la validation de nos systèmes d’assemblage, selon les objectifs convenus avec nos partenaires (délais, qualité). Pour cela, vous identifierez les problèmes techniques, rechercherez des solutions et les communiquerez aux Teams de Projets. Être le point de contact central entre les partenaires et l’équipe de projet en interne pour...


  • Geneva greater area, Schweiz Capgemini Suisse SA Vollzeit

    We are looking for a Cloud & DevOps Engineer Choosing Capgemini means choosing a company where you will be empowered to shape your career in the way you’d like, where you’ll be supported and inspired by a collaborative community of colleagues around the world, and where you’ll be able to reimagine what’s possible. Join us and help the world’s...


  • Geneva greater area, Schweiz Capgemini Suisse SA Vollzeit

    We are looking for a Cloud & DevOps Engineer Choosing Capgemini means choosing a company where you will be empowered to shape your career in the way you’d like, where you’ll be supported and inspired by a collaborative community of colleagues around the world, and where you’ll be able to reimagine what’s possible. Join us and help the world’s...