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TETeleflex Incorporated

LIMS Application Manager(m/w/x)

Bülach
Full-timeOn-siteExperienced

Managing LabWare LIMS across two sites for a global medical technology provider. 3-5 years of application support experience required. Stable operation of laboratory applications, GxP-regulated environment background.

Requirements

  • Degree in Business Informatics, IT, or comparable technical qualification
  • 3–5 years of experience in application support, maintenance, or ALM
  • Experience in project, process, or requirements engineering
  • Background in GxP-regulated environment (GAMP 5, 21 CFR Part 11, EU Annex 11)
  • Good understanding of laboratory processes
  • Mandatory Computer System Validation (CSV) experience
  • Experience in medical device or pharmaceutical industry (advantage)
  • Basic knowledge of database technologies (MS SQL Server or Oracle)
  • Basic knowledge of application architecture
  • Familiarity with SAP interfaces or ERP-integrated environments (plus)
  • German (B1 minimum), English conversational proficiency

Tasks

  • Manage LabWare LIMS environment across two sites
  • Ensure stable operation of laboratory applications
  • Process incoming requests promptly
  • Maintain system documentation
  • Monitor application performance and resource consumption
  • Communicate proactively on disruptions and planned downtime
  • Support and consult users on application handling
  • Coordinate with support teams and application developers
  • Contribute to global KPIs and strategic planning
  • Support new updates and releases
  • Maintain operational documentation
  • Ensure compliance with FDA 21 CFR Part 11 and EU Annex 11
  • Assess and mitigate application-related risks

Work Experience

  • 3 - 5 years

Education

  • Vocational certificationOR
  • Bachelor's degree

Languages

  • GermanBasic
  • EnglishBasic

Tools & Technologies

  • MS SQL Server
  • Oracle
  • SAP
  • GAMP 5
  • 21 CFR Part 11
  • EU Annex 11
  • ISO 13485
  • EU MDR
  • EU IVDR
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