Ihre Aufgaben

• Act as subject matter lead and strategic coordinator for end-to-end Analytical Instrument Lifecycle Management, including full responsibility for CAPEX processes, comprehensive project leadership of complex work packages, oversight and review of User Requirement Specifications, assurance of qualification standards, validation maintenance, audit trail review, and planning as well as execution of decommissioning processes.
• Spearhead the development, evaluation, and optimization of innovative digital solutions and data science applications to sustainably increase laboratory efficiency—e.g., through leadership of advanced projects for database queries or AI-based optimization approaches.
• Hold overall accountability for the conceptualization, implementation, and management of laboratory digitalization projects, coordinating cross-functional stakeholders (e.g., IT, operations, quality management), driving instrument connectivity, data automation, and LIMS integration across systems.
• Champion and serve as a multiplier for the successful implementation and ongoing development of the AGILE Operating System (LabExcellence, AOS tools, etc.), initiate and lead strategic improvement measures across the laboratory, and drive team knowledge sharing and coaching to foster a culture of excellence.
• Lead budget planning and CAPEX requests incl. cross-functional alignment (user, engineering/external parties, DD&T, etc.)
• Prepare User Requirement Specifications (URS)
• Ensure data integrity (ALCOA+) and traceability including 21 CFR Part 11 and GxP considerations
• Perform and document analytical instrument qualification & computerized system validation
• Plan and execute instrument decommissioning
• Act as SME within regulatory interactions and audits
• Drive the implementation of LabExcellence tools and Lab of the future initiatives
• Act as mentor and multiplier for employees
• Periodic reporting of progress into global functions
• Continuously optimize laboratory processes
• Lead and execute lab instrument interface projects (e.g. bi-directional instrument – LIMS connectivity)
• Evaluate, select, and manage vendors/partners for instrumentation integrations
• Set up and test interfaces as well as provide support for validation
• Provide support for system issues and LIMS applications
• Interface with local & global DD&T
• Perform data analyses and create queries/dashboards/control charts, etc. following SDLC standards
• Mentor and upskill scientists and data practitioners
• Present results and derive recommendations
• Interface with other sites and/or global functions to promote local solutions globally

Ihre Qualifikationen

• HTL (Higher Technical College) with a focus on Bioinformatics, Information Technology or Biomedical Analytics, or Bachelor’s degree in Bioinformatics, Information Technology, Data and digital sciences, computational biology, bioengineering, or related field (Master´s degree is an advantage)
• 5+ years of relevant professional experience, ideally with leadership or strategic project experience (including international projects is a plus)
• Proven track record in managing complex projects and driving innovation in laboratory or analytical settings
• Physical ability to handle laboratory equipment
• Additional