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Computer Systems Validation

3 maanden geleden

Utrecht, Utrecht, Nederland Capgemini Voltijd
Jouw baan als Computer Systems Validation (CSV) Engineer bij Capgemini Engineering

Capgemini Engineering zoekt een gedreven Computer Systems Validation (CSV) Engineer die verantwoordelijk zal zijn voor het testen en kwalificeren van procesinstallaties, apparatuur en gebouwen. Als CSV Engineer coördineer je zorgvuldig alle test- en kwalificatie/validatie activiteiten en ben je het centrale aanspreekpunt voor diverse interne afdelingen, zoals productie, QA en QC.

Jouw verantwoordelijkheden omvatten:

  • Opstellen en uitwerken van kwalificatieplannen, behoeftespecificaties, User Acceptance Test protocollen en kwalificatierapportages.
  • Uitvoeren van gedegen validatie en rapportage van automatisering in processen en apparatuur, waarbij je volledige verantwoordelijkheid draagt.
  • Kritisch beoordelen van validatiedocumenten om te waarborgen dat deze voldoen aan GMP-richtlijnen en andere regelgevende vereisten.
  • Actief bijdragen aan het identificeren, initiëren en implementeren van verbeteringen voor GMP-documentatie om de documentatiekwaliteit en compliance te verhogen.

    Jouw thuisbasis bij Capgemini Engineering
    De Digital Manufacturing divisie houdt zich bezig met ontwikkelingen rondom Industrie 4.0. Wij bieden end to end advies voor het creëren van smart factories. Onze collega's bezitten ruime kennis over IoT, Connectivity, Artificial Intelligence, Automation programs en Validation. Met deze kennis opereren wij in verschillende industrieën, waaronder Life Sciences, Infrastructure, Energy en Manufacturing. Vind jij het interessant te weten hoe aan de kwaliteis- en compliance eisen worden voldaan rondom COVID-19, of hoe Digital Twins een Industrie 4.0 architectuur ondersteunen voor Bluetooth toestellen? Meld je dan snel aan
    Benefits
    Capgemini Engineering biedt een dynamische werkomgeving waarin jouw groei en ontwikkeling centraal staan. Je krijgt de kans om te werken in een gepassioneerd team dat zich richt op het leveren van hoogwaardige oplossingen voor onze klanten in de life sciences sector. Naast uitdagende projecten bieden we uitstekende arbeidsvoorwaarden en mogelijkheden voor professionele ontwikkeling. Denk aan:
    • Direct een vast contract en een passend salaris;
    • Onbeperkt trainingen volgen bij onze Academy;
    • 26 vakantiedagen. Zin in een extra veel vrije tijd? Koop dan dagen bij;
    • Een premievrij pensioen;
    • Werken waar je maar wilt met onze connectiviteits- en thuiswerkvergoeding;
    • Een snelle laptop en een simkaart die je ook privé mag gebruiken.

      Wat breng je mee?
      Voor deze functie is het belangrijk dat je een studie achtergrond hebt in bijvoorbeeld levensmiddelentechnologie, (bio)procestechnologie, chemie of techniek. Daarmee heb jij namelijk passende kennis opgedaan behorend bij een life science fabrieksomgeving. Om succesvol te zijn in deze functie is het belangrijk kennis te hebben van GMP en de relevante wet- en regelgeving. Daarnaast is het belangrijk ervaring te hebben met CSV in een streng gereguleerde omgeving, en een nauwkeurige benadering van documentatie en rapportage.
      Twijfel je of je voldoende in huis hebt om deze functie te vervullen? Bij ons kun je diverse trainingen volgen die net dat extra zetje geven