CSV Engineer (m/f)
ALTRAN
Zürich, CHE , Suisse
vor 15 Tg.

Avec plus de 45'000 consultants dans le monde et générant un chiffre d’affaires d'EUR. 2.9 Mia, le Groupe Altran est le leader mondial dans les services d’ingénierie et de R&D (ER&D).

En Suisse, Altran emploie plus de 250 consultants et vise une forte croissance avec des bureaux à Zurich, Bâle, Lausanne et Genève.

Altran déploie son expertise notamment dans les secteurs suivants :

  • Sciences de la vie (Pharma, Biotech, et Dispositifs médicaux),
  • Industrie, Aéronautique, Automobile, Energie, Transports Ferroviaire,
  • Services financiers : Assurance des personnes et des biens, Assurance maladie, Réassurance, Banque
  • Secteur public
  • Titre du poste CSV Engineer (m / f)
  • Numéro de référence 14576
  • Lieu de travail Suisse / CHE - Toutes régions / Zürich
  • Type de contrat CDI Temps plein
  • Nombre minimum d’années d’expérience requis 5 ans d'expérience et plus
  • Notre offre

  • A permanent contract with the leader in innovation and high-tech engineering consulting.
  • A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR.
  • 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).

  • In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.
  • Altran deploys its expertise particularly in Life Sciences (Pharma, Biotech, and Medical Devices); Industry, Aerospace, Automotive, Energy, Railways;
  • Financial Services : P&C Insurance, Health Insurance, Reinsurance, Banking; Telecoms and Public sector.

    Vos responsabilités

  • Independent implementation and documentation of validation and qualification activities in accordance with valid specifications and project planning, in close cooperation with internal and external partners / interfaces of Operations Instrumentation, in particular for the areas of instrumentation and all custom-
  • made systems of the tech support department.

  • Co-responsible for ensuring compliance in accordance with the applicable internal guidance documents. Review of validation / qualification documents, checking for correctness of form and content.
  • Creation of validation / qualification plans and reports, as well as test plans / reports.
  • Planning and execution of validation and qualification tasks, as well as maintenance of the existing qualification documentation.
  • Qualification of equipment, like standard equipment, custom built systems or measuring equipment.
  • Validation of test sites (custom built, consisting of various subsystems including software components).
  • Validation of software and Excel workbooks, according to CSV (computerized system validation).
  • Support and expert advice to operators and the user of equipment / systems when performing validation and qualification tasks
  • Reporting, coordination and coordination of priorities with clients, partners / interfaces such as Sub-project leader, Product Leader, Line Manager and contact person from the specialist departments.
  • Collaboration in the preparation of risk analyses of equipment / systems.
  • Votre profil

  • Bachelor of Science in Engineering, Science or Medical Technology.
  • Very good understanding of complex processes in test processes and software functions.
  • Good maths skills to independently calculate the formulas of the software in Excel based on raw data, trends & correlations.
  • High technical understanding of test / process flows, and software functions to hard - / Software architectures are prerequisites for writing software test plans based on specifications.
  • EDP knowledge (SAP, MS Office) and understanding of hardware and software architectures are an advantage.
  • Experience in the regulated GxP environment, ideally the medical technology (ISO 13458, GMP, FDA 21 CFR 820).
  • Good comprehension, recognition of complex relationships, high quality awareness and a structured, systematic approach.
  • Great communication skills, information flow, coordination of different stakeholders.
  • Outstanding communication skills in English and German (compulsory).
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