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Job details

Summary

    Posted 12. may 2026

    Reference number
    25143
    get in touch

    we are here to help you with your questions.

    W

    Walentyna Dobrowolska

    +41 58 201 56 71

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    Job details

    For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a CSV Expert (Synthetic Molecule Facility).

    General Information:

    • Start Date: ASAP
    • Latest possible start date: 01.08.2026
    • Planned Employment Duration: 12 months with the possibility of extension
    • Workplace: Basel
    • Home Office: No
    • Workload: 40-60%
    • Team: 10 people
    • Traveling: No
    • Department: Basel Site Services Chapter G10 (EFHCAH)
    • Working Hours: Standard

    About the job:

    The "Synthetic Molecule Clinical and Launch Facility" (SMF) project involves modernizing the existing development and commercial launch production for drug-substance small molecules. The production control systems planned within the Synthetic Molecules Facility (SMF) project are to be qualified/validated according to CSV.

    The ideal candidate

    Possess extensive experience as a CSV expert with in-depth knowledge of process control systems (PCS) in a pharmaceutical GMP environment. Demonstrable experience in creating validation-compliant URS, specifications (GxP/CSV), and test plans, as well as experience in using electronic documentation and workflow tools (eVAL) for validation, is essential.

    Tasks & Responsibilities:

    • CSV Documentation: Leading the creation of validation-compliant User Requirements Specifications (URS) and Functional Specifications (FS) in accordance with GxP/CSV guidelines.
    • Solution's & Compliance: Ensuring that the implementation of validation activities for the process control system meets CSV requirements.
    • Execution Planning: Creating a roadmap and a detailed schedule for execution and validation.
    • Monitoring of execution: Ensuring that the requirements are implemented to the required quality, within the specified timelines and in compliance with CSV standards.
    • Interface: Act as coordinator between Technical Compliance and the implementation teams.

    Must-haves:

    • Education/degree ideally as an automation engineer or comparable qualification
    • At least 10 years of experience in CSV (Computerized System Validation) in a pharmaceutical GMP environment
    • Demonstrable experience with process control systems (PCS) or similar automation systems in production
    • Demonstrable experience in creating validation-compliant URS and specifications (GxP / CSV)
    • Very good IT/tool skills, especially regarding documentation and workflow tools for validation
    • English (good knowledge)

    Nice-to-haves:

    • Experience as a project manager of digitalization projects in a pharmaceutical GMP environment.

    Sounds interesting? Apply now – we’re looking forward to receiving your applications!

    Application Submission Deadline: 21.05.2026

    ...

    For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a CSV Expert (Synthetic Molecule Facility).

    General Information:

    • Start Date: ASAP
    • Latest possible start date: 01.08.2026
    • Planned Employment Duration: 12 months with the possibility of extension
    • Workplace: Basel
    • Home Office: No
    • Workload: 40-60%
    • Team: 10 people
    • Traveling: No
    • Department: Basel Site Services Chapter G10 (EFHCAH)
    • Working Hours: Standard

    About the job:

    The "Synthetic Molecule Clinical and Launch Facility" (SMF) project involves modernizing the existing development and commercial launch production for drug-substance small molecules. The production control systems planned within the Synthetic Molecules Facility (SMF) project are to be qualified/validated according to CSV.

    The ideal candidate

    Possess extensive experience as a CSV expert with in-depth knowledge of process control systems (PCS) in a pharmaceutical GMP environment. Demonstrable experience in creating validation-compliant URS, specifications (GxP/CSV), and test plans, as well as experience in using electronic documentation and workflow tools (eVAL) for validation, is essential.

    Tasks & Responsibilities:

    • CSV Documentation: Leading the creation of validation-compliant User Requirements Specifications (URS) and Functional Specifications (FS) in accordance with GxP/CSV guidelines.
    • Solution's & Compliance: Ensuring that the implementation of validation activities for the process control system meets CSV requirements.
    • Execution Planning: Creating a roadmap and a detailed schedule for execution and validation.
    • Monitoring of execution: Ensuring that the requirements are implemented to the required quality, within the specified timelines and in compliance with CSV standards.
    • Interface: Act as coordinator between Technical Compliance and the implementation teams.

    Must-haves:

    • Education/degree ideally as an automation engineer or comparable qualification
    • At least 10 years of experience in CSV (Computerized System Validation) in a pharmaceutical GMP environment
    • Demonstrable experience with process control systems (PCS) or similar automation systems in production
    • Demonstrable experience in creating validation-compliant URS and specifications (GxP / CSV)
    • Very good IT/tool skills, especially regarding documentation and workflow tools for validation
    • English (good knowledge)

    Nice-to-haves:

    • Experience as a project manager of digitalization projects in a pharmaceutical GMP environment.

    Sounds interesting? Apply now – we’re looking forward to receiving your applications!

    Application Submission Deadline: 21.05.2026

      get in touch

      we are here to help you with your questions.

      W

      Walentyna Dobrowolska

      +41 58 201 56 71
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