Aufgaben

  • Provide CSV expertise with focus on production
  • Define user requirements and functional specifications
  • Evaluate prototypes and support system demonstrations
  • Support cross-functional project teams with technical and regulatory input
  • Author/support validation plans, protocols, and reports
  • Oversee or execute IQ, OQ, PQ validation activities
  • Review test results, address incidents, ensure compliance
  • Troubleshoot system functionality and validation issues
  • Support audits and inspections, prepare documentation
  • Identify opportunities for process and system improvements
  • Support system updates/upgrades ensuring compliance

Qualifikationen

  • 4+ years CSV experience in Production
  • Strong knowledge of GAMP 5 and Data Integrity principles
  • Experience as SME supporting audits and inspections
  • Familiarity with Cloud systems and validation considerations
  • Agile methodology knowledge is a plus
  • Fluent in English and German
  • Experience with ERP, MES, SCADA, Trackwise preferred
  • Independent, task-focused, and collaborative
  • Strong communication, influencing, and problem-solving skills
  • Good organization, autonomy, and ability to manage multiple priorities