Senior Application Manager

Position Summary

We are looking for an experienced LIMS Application Manager to take ownership of our LabWare LIMS environment across two manufacturing sites (Switzerland and Germany). The role sits within the IT Production Systems team and covers day-to-day application management, GxP compliance, and active participation in an ongoing platform migration and LIMS version upgrade. You'll be working in a regulated medical device environment (FDA 21 CFR Part 11, EU Annex 11, ISO 13485) and coordinating closely with internal stakeholders, system vendors, and external implementation partners.

Principal Responsibilities

• Optimal operation of global laboratory applications and information systems for which ownership has been assumed
• Processing of all relevant requests (Incidents, Service Requests and Change Requests) is ensured
• System documentation (CIs, CSV documents, …) is maintained accordingly
• Ensuring monitoring of ongoing global application operations within the system ownership; coordinating and overseeing all activities aimed at tracking availability, recoverability (continuity), performance and resource consumption of applications
• Informing users and IT Support of disruptions or planned downtime of the applications under responsibility
• Global consulting and support of users in the areas of application and process handling
• Defining global support processes for laboratory applications and ensuring coordination between support teams, application developers and local Application Managers
• Global monitoring of systems and 2nd/3rd level support
• Creation of global KPIs that contribute to supporting global strategic decisions
• Strategic planning of updates/releases affecting the entire group
• Support (specification, testing, rollout) for new updates/releases
• Drafting/contributing to the creation of global Change Requests
• Ensuring that all documentation required for application operations is defined and in place. (Operations manual, user manual, guidelines etc.)
• Ensuring system compliance with FDA 21 CFR Part 11 and EU Annex 11
• Co-determination of the migration strategy for local systems into global IT
• Globally assessing risks associated with the Applications and proactively mitigating them
• Globally assessing risks associated with the Applications and proactively mitigating them
• LabWare LIMS V8 upgrade in progress , you'll take over tracking and coordination of open defects and UAT activities
• Active ERP/infrastructure migration project  with a defined deadline

Education / Experience Requirements

• Business Informatics; Swiss Federal Diploma in IT; alternatively: higher commercial or technical vocational qualification with deep IT knowledge
• Support and maintenance of applications and information systems (> 8 years of experience)
• Project management; process management; requirements engineering (> 8 years of experience)
• Application Management and/or Application Lifecycle Management (> 10 years of experience)

Specialized Skills / Other Requirements

• Further training in project and process management
• The future jobholder pursues continuous professional development to meet the requirements of the role. Development activities include: study of specialist literature, attendance at courses, seminars and conferences role-specific training takes place within the defined and approved departmental budget
• Hands-on experience with LabWare LIMS (administration, configuration, workflow management and user support); knowledge of LabWare Basic (LWB) scripting is a strong advantage
• Experience with Agilent OpenLab CDS (Chromatography Data System) in a laboratory environment
• Familiarity with NuGenesis Scientific Data Management System (SDMS) for data capture and archiving
• Experience with GuSLab laboratory management software
• Good understanding of laboratory processes (sample management, stability testing, Certificate of Analysis generation, instrument integration)
• Experience with SAP QM interface integration (IDI/QMIDI) in a LIMS context is a strong advantage
• Mandatory: Computer System Validation (CSV) experience in a GxP-regulated environment (GAMP 5, 21 CFR Part 11, EU Annex 11)
• Experience in the medical device or pharmaceutical industry (ISO 13485, EU MDR/IVDR) preferred
• Ideally knowledge of the applications to be managed
• Database technology (MS SQL Server, Oracle), communication protocols, application architecture; (Agile) application development, web services, portal technology, SAP IDocs
• Ideally: IT server and network infrastructure

• German (language level B1)
• English (written/spoken) conversational proficiency