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LIMS Application Manager(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 3 - 5 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Deutsch – Grundkenntnisse
- Englisch – Grundkenntnisse
Tools & Technologien
- MS SQL Server
- Oracle
- SAP
- GAMP 5
- 21 CFR Part 11
- EU Annex 11
- ISO 13485
- EU MDR
- EU IVDR
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LIMS Application Manager(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 3 - 5 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Deutsch – Grundkenntnisse
- Englisch – Grundkenntnisse
Tools & Technologien
- MS SQL Server
- Oracle
- SAP
- GAMP 5
- 21 CFR Part 11
- EU Annex 11
- ISO 13485
- EU MDR
- EU IVDR
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Teleflex Incorporated
Branche
Healthcare
Beschreibung
Teleflex is a global provider of medical technologies focused on improving health and quality of life through innovative solutions.
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