Computer System Validation

vor 3 Monaten


Bern, Schweiz CSL Vollzeit

Your Role

The Computer System Validation Lead – Lab Execution Systems (LES), 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 in Melbourne, Australia or overseas.

Your Responsibilities

Reporting to the Global CSV Lead you will:

Implement LES CSV strategy across CSL Manage the CSV program for Lab Execution Systems and application interfaces Owner of the LES validation strategy in alignment with Quality Oversee the preparation, delivery, and execution of CSV deliverables for Lab Execution Systems Coordinate with Quality, Site and Global validation team to build alignment of LES validation expectations and maintain the validated state of LES platforms Develop processes and maintain platforms Manage System Development Lifecycle and validated state of LES platforms Accountable for the Periodic Review process for documentation and systems Use validation lifecycle management applications such as Kneat to support CSV phases

Your Experience

Bachelor's in Engineering, Computer Sciences, or similar field 7+ years' experience with CSV methodologies in Lab Execution Systems, operation IT, OT, or Automation position with a good understanding of pharma, biologics and chemistry Experience in writing, reviewing and executing CSV documents in a GAMP 5 CSV framework Demonstrated knowledge and experience with CSV, SDLC, and Data Integrity principles Experience with Lab Execution Systems technologies that may include Laboratory Information Management Systems (LIMS), Chromatography Data Acquisition System (CDAS) and Laboratory Data Management systems Knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5 Experience using ALM platforms such as Kneat and Codebeamer to support CSV

To apply submit your CV no later than Monday 15th July 2024.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you.



  • 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 at CSL.This role is part of a global function and can be based from our manufacturing sites.Key ResponsibilitiesImplement the CSV strategy...


  • 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...

  • Validation (Csv)

    vor 3 Monaten


    Bern, Schweiz Experis Vollzeit

    CSV Engineer Occupation % 100% **Major Interfaces** - Technical Services and all other departments on site which rely on CSV services **Important**: In charge of Computer System Validation (CSV) activities for Technical Services department in order to ensure that: - Validation phases are performed according to global and local company policies and...

  • Validation Strategist

    vor 2 Wochen


    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...


  • 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...


  • 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 Engineer

    vor 2 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 DescriptionKey ResponsibilitiesAssess and produce the CSV...

  • System Engineer

    vor 2 Wochen


    Bern, Bern, Schweiz Sécheron Hasler Group Vollzeit

    About the RoleWe are seeking a highly skilled and experienced System Engineer to join our team at Sécheron Hasler Group. As a key member of our team, you will be responsible for implementing activities related to new and existing products.Main ResponsibilitiesRequirements Management: Create and manage system specifications, ensuring that all requirements...


  • Bern, Schweiz Swisslinx Vollzeit

    On the behalf of one of our clients in pharmaceutical industry a Laboratory System Analyst. The role implies collaborating with stakeholders to ensure laboratory are compliant with Data Integrity guidelines by implementing a Data Audit Trail Review process. With proactivity and self-responsiveness. This is a 12-month contract, ideal start date mid-September,...

  • System Engineer

    Vor 6 Tagen


    Bern, Bern, Schweiz Sécheron Hasler Group Vollzeit

    About the RoleWe are seeking a highly skilled and motivated System Engineer to join our team at Sécheron Hasler Group. As a key member of our team, you will be responsible for implementing activities related to new and existing products.Main ResponsibilitiesRequirements management for creating the System SpecificationGenerates and manages the technical...

  • IT Director

    vor 2 Wochen


    Bern, Bern, Schweiz HELVETICA PARTNERS Vollzeit

    Head of IT (IT QA / CSV / Standards) - German SpeakingWe are seeking a highly skilled IT professional to lead our IT Quality Assurance, CSV, and Standards teams. The ideal candidate will have a strong background in IT project management, risk management, and quality assurance.Your Key Responsibilities:Oversee the personnel and technical management of IT...

  • IT Director

    vor 1 Woche


    Bern, Bern, Schweiz HELVETICA PARTNERS Vollzeit

    Head of IT (IT QA / CSV / Standards) - German Speaking - SEMWe are seeking a seasoned IT professional to lead our IT Quality Assurance, CSV, and Standards teams. The ideal candidate will have a strong background in project management, IT risk and quality management, and computer system validation.Your Role:Oversee the personnel and technical management of IT...

  • CSV Expert

    vor 2 Monaten


    Bern, Schweiz Consultys Vollzeit

    Perform CSV activities associated with ensuring that business processes required to operate a highly automated & integrated large-scale bio-production facility are qualified and maintained in a validated stateProvide input on improvement of testing documentationSupport the implementation and adoption of the global CSV program and remediationSupport data...

  • Csv Consultant

    vor 4 Monaten


    Bern, Schweiz Experis Vollzeit

    CSV Consultant **Experis is the global leader in professional resourcing and project-based workforce solutions.** **For our client, a leading Pharmaceutical company in Bern, we are looking for a CSV Consultant.** **Location: Bern** **Duration of contract: 9 months** **Responsibilities** You will be in charge of Computer System Validation (CSV)...

  • System Engineer

    vor 2 Monaten


    Bern, Schweiz Sécheron Hasler Group Vollzeit

    HaslerRail AG is proud of its more than 130 years' tradition in the field of railway technology. We are the world leader in on-board electronics for railway vehicles with a steadily growing product portfolio. All over the world, the name Hasler is synonymous with Swiss quality in the railway market. The head office of HaslerRail AG is located in Berne,...


  • Bern, Bern, Schweiz Randstad Staffing Vollzeit

    Job SummaryWe are seeking a highly motivated and organized Quality Control Specialist to join our team at Randstad Staffing. As a Quality Control Specialist, you will be responsible for ensuring the quality of our products and services by coordinating equipment/system qualification and validation activities within the QC department.Key...


  • Bern, Bern, Schweiz Randstad Staffing Vollzeit

    Job SummaryWe are seeking a highly motivated and organized Quality Control Specialist to join our team at Randstad Staffing. As a Quality Control Specialist, you will be responsible for ensuring the quality of our products and services, and for implementing processes to improve our quality management system.Key ResponsibilitiesCoordinate equipment/system...


  • Bern, Bern, Schweiz Randstad (Schweiz) AG Vollzeit

    About the RoleWe are seeking a highly motivated and organized Quality Control Specialist to join our team at Randstad (Schweiz) AG. As a Senior Associate Specialist QC Services, you will play a key role in ensuring the quality and integrity of our products.Key ResponsibilitiesCoordinate equipment/system qualification and validation activities within the QC...


  • Bern, Bern, Schweiz Randstad (Schweiz) AG Vollzeit

    Job DescriptionWe are seeking a highly motivated and organized Senior Associate Specialist QC Services to join our team in Bern, Switzerland. As a key member of our Quality Control department, you will play a crucial role in ensuring the quality and integrity of our products.Key ResponsibilitiesCoordinate equipment/system qualification and validation...


  • Bern, Bern, Schweiz Randstad - Medium prio Vollzeit

    About the RoleWe are seeking a highly motivated and organized Quality Control Specialist to join our team at Randstad. As a Quality Control Specialist, you will be responsible for ensuring the quality of our products and services.Key ResponsibilitiesCoordinate equipment/system qualification and validation activities within the Quality Control department,...