CSV Validation Specialist

vor 2 Wochen

Bern, Bern, Schweiz Capgemini Vollzeit

About Capgemini Engineering

At Capgemini Engineering, we value excellence, diligence, responsibility, dynamism, and innovation. We offer a diverse workplace and invite you to be part of our success story, where we provide training, tools, and foundations for your professional and personal growth.

Job Description

We are looking for an experienced CSV Engineer to join our team.

  • Assess and produce CSV packages on assigned projects, taking accountability for the work to be produced.
  • Plan, coordinate, and execute all phases for computer system validation of production and QC Lab systems, including validation plans, FMEA, RTM, DQ, IQ, OQ, PQ test scripts.
  • Prepare, review, and approve technical and GMP-related documentation, such as URS, impact/risk assessment, Master plans, qualification/validation documentation.
  • Understand customer needs and define electronic records requirements for computerized systems, adhering to regulations and company standards.
  • Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems.
  • Validation planning for base business, including interaction with IT, Maintenance Automation, and Quality Operations groups.
  • Contribute to ensuring that changes introduced in the organization of systems, procedures, processes, and formulas are managed, assessing and resolving all aspects of equipment/computerized systems commissioning and qualification processes.

Your Profile

  • Bachelor/Masters Degree in technical or natural sciences.
  • A minimum of 4 years of working experience with CSV.
  • A minimum of 3 years of working experience within pharma or a biotech company.
  • Knowledge of CSV requirements according to FDA 21CFR part 11/EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines.
  • Experience in defining strategy and validating computerized manufacturing equipment (CSV context).
  • Excellent communication skills.
  • Analytical thinking and problem-solving ability.
  • Ability to work under minimal supervision, assess priorities, and work well under pressure in a fast-paced environment.
  • Ability to effectively work as part of a multidisciplinary, international team.
  • Fluent in English.

Benefits

  • Between 30% and 70% remote work in agreement with your manager and client needs (40% for cross-border due to tax regulations).
  • 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.

  • CSV Validation Specialist

    vor 3 Wochen

    Bern, Bern, Schweiz Consultys Vollzeit

    Job DescriptionAt Consultys, we are seeking a highly skilled CSV Validation Specialist to join our team. As a CSV Validation Specialist, you will play a critical role in ensuring that our business processes are qualified and maintained in a validated state.Key Responsibilities:Provide input on the improvement of testing documentation to ensure compliance...

  • CSV Validation Specialist

    vor 4 Wochen

    Bern, Bern, Schweiz Consultys Vollzeit

    Job Title: CSV Validation SpecialistAt Consultys, we are seeking a highly skilled CSV Validation Specialist to join our team. As a CSV Validation Specialist, you will play a critical role in ensuring that our business processes are qualified and maintained in a validated state.Key Responsibilities:Provide input on the improvement of testing documentation to...

  • CSV Validation Specialist

    vor 1 Woche

    Bern, Bern, Schweiz Consultys Vollzeit

    Job Title: CSV Validation SpecialistAt Consultys, we are seeking a highly skilled CSV Validation Specialist to join our team. As a CSV Validation Specialist, you will play a critical role in ensuring that our business processes are qualified and maintained in a validated state.Key Responsibilities:Provide input on the improvement of testing documentation to...

  • CSV Validation Specialist

    vor 1 Monat

    Bern, Bern, Schweiz Consultys Vollzeit

    Job DescriptionAt Consultys, we are seeking a highly skilled CSV Validation Specialist to join our team. As a CSV Validation Specialist, you will play a critical role in ensuring that our business processes are qualified and maintained in a validated state.Key ResponsibilitiesProvide input on the improvement of testing documentation to ensure compliance with...

  • CSV Validation Specialist

    Vor 4 Tagen

    Bern, Bern, Schweiz Capgemini Vollzeit

    About the RoleAt Capgemini Engineering, we are seeking an experienced CSV Validation Specialist to join our team. As a CSV Validation Specialist, you will be responsible for assessing and producing CSV packages on assigned projects, taking accountability for the work to be produced.Key ResponsibilitiesPlan, coordinate, and execute all phases for computer...

  • CSV Validation Specialist

    vor 3 Wochen

    Bern, Bern, Schweiz Capgemini Vollzeit

    About Capgemini EngineeringAt Capgemini Engineering, we value excellence, diligence, responsibility, dynamism, and innovation. We offer a diverse workplace and invite you to be part of our success story, where we provide training, tools, and foundations for your professional and personal growth.Job DescriptionWe are looking for an experienced CSV Validation...

  • CSV Validation Specialist

    vor 1 Woche

    Bern, Bern, Schweiz Capgemini Vollzeit

    About UsAt Capgemini Engineering, we value excellence, diligence, responsibility, dynamism, and innovation. We offer a diverse workplace and invite you to be part of our success story, where we provide training, tools, and foundations for your professional and personal growth.Job DescriptionWe are looking for an experienced CSV Validation Specialist to join...

  • CSV Validation Specialist

    vor 1 Monat

    Bern, Bern, Schweiz Capgemini Vollzeit

    About Capgemini EngineeringWe value excellence, diligence, responsibility, dynamism, and innovation. Our diverse workplace offers opportunities for professional and personal growth. We are looking for an experienced CSV Engineer to join our team.Job ResponsibilitiesAssess and produce CSV packages on assigned projects, taking accountability for the work...

  • CSV Validation Specialist

    vor 16 Stunden

    Bern, Bern, Schweiz Capgemini Vollzeit

    About UsAt Capgemini Engineering, we strive for excellence in delivering high-quality services. Our team of experts is dedicated to providing a dynamic and innovative work environment that fosters growth and development.Job DescriptionAssess and produce CSV packages for assigned projects, ensuring accountability for the work produced.Plan, coordinate, and...

  • CSV Engineer

    vor 2 Monaten

    Bern, Bern, Schweiz Capgemini Vollzeit

    About Capgemini EngineeringAt Capgemini Engineering, we value excellence, diligence, responsibility, dynamism, and innovation. We offer a diverse workplace and invite you to be part of our success story, where we provide training, tools, and foundations for your professional and personal growth.Job DescriptionKey ResponsibilitiesAssess and produce the CSV...

  • CSV Specialist

    vor 1 Monat

    Bern, Bern, Schweiz Avacone Iberia S.L. Vollzeit

    Job Title: CSV ConsultantWe are seeking a skilled CSV Consultant to join our team at Avacone Iberia S.L.Key ResponsibilitiesThe successful candidate will be responsible for:Managing and executing CSV projects for customers in the life science sectorEvaluating and creating gap analyses, CSV documents, and data governanceEnsuring compliance with relevant...

  • CSV Specialist

    vor 1 Monat

    Bern, Bern, Schweiz Avacone Iberia S.L. Vollzeit

    CSV ConsultantWe are seeking a skilled CSV Consultant to join our team at Avacone Iberia S.L.Key ResponsibilitiesAs a CSV Consultant, you will be responsible for:Managing and executing CSV projects for customers in the life science sectorEvaluating and creating gap analyses, CSV documents, and data governanceEnsuring compliance with relevant regulations,...

  • Validation Strategist

    vor 2 Monaten

    Bern, Bern, Schweiz CSL Vollzeit

    About the RoleThe Computer System Validation Lead will be responsible for executing the Computerized System Validation (CSV) strategy and deliverables for global and Lab Execution Supporting Systems and related interfaces.This role is part of a global function and can be based from our manufacturing sites.Key ResponsibilitiesImplement CSV strategy across...

  • Computer System Validation Expert

    vor 2 Monaten

    Bern, Bern, Schweiz Capgemini Vollzeit

    About Capgemini EngineeringAt Capgemini Engineering, we value excellence, diligence, responsibility, dynamism, and innovation. We offer a diverse workplace and invite you to be part of our success story, where we provide training, tools, and foundations for your professional and personal growth.Job DescriptionKey ResponsibilitiesAssess and produce the CSV...

  • Senior Equipment Validation Specialist

    vor 3 Wochen

    Bern, Bern, Schweiz Johnson & Johnson Vollzeit

    Job SummaryWe are seeking a highly skilled and experienced Senior Equipment Validation Specialist to join our Quality Control team at Johnson & Johnson. As a key member of our team, you will be responsible for implementing and maintaining qualification, validation, and data integrity policies, procedures, and programs related to equipment and automated...

  • Senior Equipment Validation Specialist

    vor 1 Tag

    Bern, Bern, Schweiz Johnson & Johnson Vollzeit

    Job SummaryWe are seeking a highly skilled Senior Equipment Validation Specialist to join our team at Johnson & Johnson. The successful candidate will be responsible for implementing and maintaining qualification, validation, and data integrity policies, procedures, and programs related to equipment and automated systems.Key ResponsibilitiesPlan and organize...

  • Senior Equipment Validation Specialist

    vor 1 Woche

    Bern, Bern, Schweiz Johnson & Johnson Vollzeit

    Job SummaryWe are seeking a highly skilled and experienced Senior Equipment Validation Specialist to join our team at Johnson & Johnson. The successful candidate will be responsible for implementing and maintaining qualification, validation, and data integrity policies, procedures, and programs related to equipment and automated systems.Key...

  • Laboratory Execution Systems IT Specialist

    Vor 7 Tagen

    Bern, Bern, Schweiz CSL Vollzeit

    Job SummaryCSL Behring is seeking a highly skilled Laboratory Execution Systems IT Specialist to join our team in Bern, Switzerland. As a key member of our IT team, you will be responsible for maintaining and supporting our Quality Control (QC) computerized laboratory systems.Main ResponsibilitiesTechnical Support & Troubleshooting: Analyze and resolve...

  • Laboratory Execution Systems IT Specialist

    vor 1 Woche

    Bern, Bern, Schweiz CSL Vollzeit

    Job Title: Laboratory Execution Systems IT SpecialistCSL Behring is a global biotherapeutics leader driven by its promise to save lives. We are seeking a highly skilled Laboratory Execution Systems IT Specialist to join our team in Bern, Switzerland.Job Summary:The Laboratory Execution Systems IT Specialist will be responsible for maintaining and supporting...

  • Senior Validation Specialist

    vor 2 Monaten

    Bern, Bern, Schweiz Agap2 Vollzeit

    About the RoleWe are seeking a highly skilled CQV Engineer to join our team at Agap2. As a consultant, you will be responsible for supporting clients in various projects within the Life Science sector.Main Responsibilities:Preparation and execution of Commissioning & Qualification activitiesEnsuring milestone dates are achievedProviding support in Design...