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Jobdetails

Zusammenfassung

    veröffentlicht am 12. mai 2026

    Referenznummer
    25143
    nimm Kontakt mit uns auf

    Wir sind hier, um dir bei deinen Fragen zu helfen.

    W

    Walentyna Dobrowolska

    +41 58 201 56 71

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    Jobdetails

    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

      nimm Kontakt mit uns auf

      Wir sind hier, um dir bei deinen Fragen zu helfen.

      W

      Walentyna Dobrowolska

      +41 58 201 56 71
      verwandte Jobsalle Fachkrankenpfleger Jobs in Basel
      • Rust Software Engineer

        • Rotkreuz, Zug
        • Temporär
        <br />Looking for a Rust expert (2+ years) to drive the development of high-quality medical device software. You bring strong problem-solving skills, a collaborative mindset, and the ability to lead by example in a diverse, cross-functional environment.<p><br />General Information:</p><ul><li>Planned duration: 31.12.26</li><li>Extension (in case of limitation): yes</li><li>Workload: 80-100%</li><li>Home Office: 2 days onsite required</li><li>Team: 10-12</li><li>Working hours: Standard</li></ul><p><br />Tasks & Responsibilities:</p><ul><li>Develop and maintain software solutions by applying in-depth technical knowledge and problem-solving skills, while ensuring compliance with regulatory standards for medical software</li><li>Ensure the timely delivery of high-quality software for medical devices that meets both the company's standards and customer needs, influencing the success of the team and broader project outcomes</li><li>Communicate complex technical concepts effectively, fostering an environment of collaboration and continuous learning within and across diverse and intercultural teams</li><li>Empower your team members to take ownership of their work and leading by example to foster teamwork and mentorship</li></ul> <p>Must Haves:</p><ul><li>Bachelor’s degree or equivalent practical experience in a specialized field related to software development or engineering </li><li>Several years of proven experience in software development, with a demonstrated passion and hands-on professional experience working with Rust for at least two years incl. a solid understanding of Rust's core concepts (ownership, borrowing, and lifetimes), experience with asynchronous programming in Rust (e.g., using async/await) and familiarity with common Rust libraries and frameworks (e.g., tokio, actix-web, rocket, serde, sqlx)</li><li>Hands-on experience with modern system architectures like event-driven architecture and DDD, quality-driven practices such as TDD and BDD, or containerization technologies like Kubernetes is a plus</li><li>Capable of solving complex issues creatively and effectively, using a multi-faceted approach based on thorough analysis to resolve complex technical challenges </li><li>Excellent communication skills with the ability to foster an inclusive and diverse environment as well as collaborate effectively within and across teams </li><li>Motivation to make an impact to your fellow team members, our company, our customers and our patients</li><li>Leads by example to foster cross-functional value delivery and to establish a psychologically safe working environment and empowers its own team and holds people accountable by creating conditions for ownership</li><li>Experiences as a Technical Lead within a team is a plus</li><li>Certified ISAQB or equivalent is a plus</li><li>English fluency is a MUST, German is a plus</li></ul><p><br />We thank you for your application!</p>
        published on 23. April 2026
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