Ruhr Region
Since Jan. 2022 - Global Process Manager for our "new" global LIMS (GLIMS) system at Bayer in coorporation with TCS and LabVantage: - supporting URS designing and correct phrasing of business requirements (Bayer) - designing business workflows by using Visio - defining global requirements to support a global rollout at different sites at Bayer - Core Team member as GPM for both pilots (Consumer Health and Pharma) - considering lessons learned for designing a new system (as LIMS expert and GPM for the already existing GLMW-System Global LabMiddleWare (GLMW) process manager: - responsible for the business process workflow for using global LabMiddleWare (LabVantage) at Bayer - take care of any configuration or customization changes by following GxP guidelines - supporting additional site roll outs at Bayer - keep up GxP status of the system (periodic reviews, supporting audits) - Supporting solution designing for new enhancement requests - Evaluation of local site impact for any configuration or customization change (especially for enhancement requests) - Risk assessments - part of incident management (evaluation if any impact on other sites is expected) - Designing master data management process from global perspective (shared master data concept across the sites) LIMS Expert (worked many years as a Lab technician in different Labs under GMP conditions and also for 2 years in the global LIMS team to make the system usable for the Labs): - supporting Labs or master data manager for designing testmethod or local process flows for master data management or Sample handling in our LIMS System - SAP interface expert (customization in our LIMS System) - supporting master data transfer activities (from validation system to productive system) if needed - first and second level support in local sites - LIMS User or master data manager trainings - For new enhancements: Demos and Trainings for users if required - Designing master data management workflows (business process)
Supporting the global team to improve our global LabMiddleWare system (LabVantage 7.0.11) as a local business expert for master data management (SAP and LIMS) and as a LIMS expert (Sample Life cycle) - Close cooperation with the internal Bayer Business Services, TCS (TATA Consulting Services) and the local teams in Wuppertal (master data manager and LIMS user) - Identification of problems and errors in the current configuration of the system, creation and maintenance of a punch list - Assistance in prioritizing the issues and errors in the punch list - Support in the creation of rough specs to find solutions together with the development team using the Scrum method (monthly determination of a scope and focus on high-priority problems or errors - use of GIRA, which supports the Scrum method) - Creation of suitable test scenarios for the developed solutions - Testing of the developed solutions from a business point of view and feedback to the development team - Execution of official UATs (User Acceptance Tests) in the digital validation tool "ValGenesis" - Involvement and close contact with the involved laboratories, if necessary to prioritize when errors or problems are reported in daily suage of the LIMS system (updating the punch list if needed to track the processing status) - Training of the laboratory staff or the master data manager for important changes in the software - Adaptation of the global instruction to improve the processes workflow and increase efficiency for the creation and maintainence of global and local master data in LIMS (LabVantage) - Updating local SOP and creation of process flows for master data management, establish a required change management and track system (tracked GxP processes)
SAP Master Data Manager - Designing inspection plans in SAP QM - Setup different Operations for each Lab - Setup different MIC (master inspection characteristics) and multiple specifications per Operation - Preparing inspection plans for downloading into our LIMS system (global LabMiddleWare System) LIMS Master Data Manager - Downloading inspection plans from SAP QM into LIMS (global LabMiddleWare System) - Checking and Approving master data - Enrichment of the SAP master data in LIMS to support paperless Lab in QC area - Designing Test methods, Parameterlists, limits, Sample and QC Templates - Master Data Validation and transport to production system - LIMS training for end user (master data management and LIMS handling in QC Labs) - Creation of new work instructions (for master data management in LIMS and operating with the LIMS system in QC Labs) - Creation of visio charts to visualize the process flow (master data management and LIMS Sample Life Cycle in QC Labs)
Tätigkeiten: - Vorbereitung und Durchführung von Fermentationen im 1L-DASGIP und 2L-Laborfermenter-Maßstab zur Entwicklung von Ganzzell-Biokatalysatoren - Vorbereitung der Nährmedien, Feedlkösungen und Korrekturmitteln - Montage der Reaktoren und Anfahren der Kontroll-Software - Überwachung der Kultivierungs- und Biotransformationsphasen - Aufnahme von online- und offline-Messdaten durch Probennahme und -vorbereitung - Dokumentation der Experimente, Prozesse und gemessenen Daten - Weiterentwicklung der verwendeten Dokumentations- und Auswertetabellen - technische Verantwortung für die Autoklaven - Makro-Programmierung in Excel zur automatisierten Auswertung von Messdaten - Durchführung von Mikrotiterplattenassays zur quantitativen Aktivitätsbestimmung
Tätigkeitsbereiche: - Erstellung von Arbeitsanweisungen für Labortätigkeiten und Assays - Betreuung von Auszubildenen, Studenten, Praktikanten - Zuständig für den Materialeinkauf des Labors Screening - Unterstützung des Laborleiters bei dem Aufbau eines neues Screeninglabors - Etablierung enzymatischer Assaysysteme zur Wirkstofftestung - Screening von Naturstoffen inklusive Hit-Validierung - Validierung von Testsystemen mit Hilfe ausgewählter Referenzsubstanzen - Etablierung, Durchführung und Dokumentation antimikrobieller Assays - Auswertung und Bewertung von Screeningdaten mit Hilfe von PRISM - Optimierung und Anpassung von Roboterprotokollen zwecks Handling von Mikrotiterplatten - Fermentation bis zum 30 Liter Maßstab - Extraktion von Pflanzenmaterialien sowie Bakterien- und Pilzkulturen - Pflege der InterMed Discovery Stammsammlung - Durchführung von analytischer und präparativer HPLC - Datenbankpflege (Access)