Talent.com
Diese Stelle ist in deinem Land nicht verfügbar.
CSV Engineer

CSV Engineer

CTCValais, CH
Vor 7 Tagen
Stellenbeschreibung

Main Responsibilities :

  • Acting as subject matter expert (SME) on following Companies CQV / CSV standards
  • CSV person of contact of the assigned system till the handover to the operation organization
  • Participate to the system impact assessment as CSV SME
  • Define with EMR and Package Units vendor the most appropriate design for vertical integration in the environment
  • Create the requested CSV documents according to companies’ SOP’s and Guidelines
  • Organize the reviews of the CSV documents till last QA approval
  • Participate to the FAT & SAT
  • Create the tests protocols and execute the tests
  • Close collaboration with CSV Lead or CQV Lead
  • Responsible for ensuring that SGIE projects in Visp are compliant with the global CQV guidelines,
  • aligned with local procedures and detect / resolve potential gaps in line with companies’ continuous improvement vision
  • Participate in inspection as companies Project CSV-representative

Qualifications and Experience :

  • Relevant working / residency permit or Swiss / EU-Citizenship required
  • Technical degree (bachelor level) in engineering or applied science, post graduate qualification preferred
  • Significant experience in automation
  • Extensive experience in vertical integration and data management under validated computer systems.
  • Minimum of 5+ years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects. Familiarity with biologics (mammalian, CGT) as well as chemical manufacturing technologies desirable.
  • Significant experience in regulated pharmaceutical industry and / or engineering company with proven experience on planning CQV activities, leading large senior reports and high

    • understanding / management of KPIs.

  • Strong knowledge of ISPE GAMP5 and ASTM guidelines with proven experience on large and complex projects.
  • Proven management experience in an EMA / FDA regulated environmental with very good knowledge of current ICH, PIC / S, EU and US regulatory requirements and their implementation.
  • Experience in People Management (internal and external) with respect to organizational aspects, coaching and development.
  • Solid collaboration and influencing skills and the ability to work together with teams and individuals in a highly matrix environment.
  • Language : Excellent command of English and proven knowledge in German necessary (read and write) and other desirable.
  • Strong analytical skills. Ability to conduct in-depth analysis of complex / large data sets, draw conclusions accordingly, and prepare and support decisions.
  • Experience at working both independently and in a team-oriented environment.
  • Ability to effectively prioritize and execute tasks in a fast-paced environment.
  • Strong written and oral communication skills.
  • Willing and able to train / support colleagues