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    CSV Engineer French-English - Lausanne, Schweiz - EURHASI

    EURHASI
    EURHASI Lausanne, Schweiz

    vor 1 Woche

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    Beschreibung
    Job Description

    EURHASI is recruiting for its client a CSV Engineer French-English

    Our 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, Quality management (Quality Assurance, Qualification/Validation, QC,...), Regulatory Affairs, Manufacturing, Maintenance, Operational Excellence, and Project Management.

    Information : The client accepts applications requiring administrative procedures for a work authorization (residence permit, work permit, various authorizations, etc.) under certain conditions: EU/EFTA member state nationals only.

    Mission

    About the job:

    • You provide support and expertise on Computer System Validation activities
    • You run CSV projects execution ensuring timelines are met
    • You write validation plan, URS, FS, risk assessment, IQ/OQ/PQ protocols, reports, VSR, applicable SOPs and training documents
    • You train and coach people
    • You maintain expertise in current and emerging cGMP requirements and quality trends
    • You work independently and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule
    • You lead system qualification efforts and are the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as
    • they apply
    • You develop new and pragmatic approaches to support the industry in this field


    Profil

    Profile

    • You hold a Master's degree in a scientific or engineering discipline
    • You possess at least 3 years of experience in the field of computer system validation that you developed in Pharmaceuticals,
    • Biotechnologies or Medical devices industries
    • You have experience with all pertinent industry best practices (GAMP 5, etc.) including development and execution of all applicable system life cycle deliverables
    • (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report)
    • You have previous automation experience and experiences with MES, ERP and LIMS
    • You possess experience in project execution within at least one area of systems validation – e.g., laboratory equipment, facilities, utilities, manufacturing equipment,
    • metrology equipment, information systems
    • You are fluent in French with good knowledge of English
    • You are willing to work in Switzerland

    Minimum expected qualifications :

    • The candidate must be willing to work in Switzerland
    • at least 3 years of experience in the field of computer system validation that you developed in Pharmaceuticals, Biotechnologies or Medical devices industries
    • Fluency in English


    Informations contractuelles

    • Teleworking
    • Very competitive compensation package with exceptional Pension scheme
    • 5 weeks paid holidays
    • ongoing Training & Development opportunities.

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