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Lead Engineer Qualification Specialist

vor 1 Monat


Stuttgart, Baden-Württemberg, Deutschland Exyte Vollzeit
About the Role

We are seeking a highly skilled Lead Engineer Qualification to join our team at Exyte Central Europe. As a key member of our Bio Life Sciences sector, you will be responsible for handling project-specific qualification and validation activities, ensuring compliance with current GMP regulations.

Key Responsibilities
  • Prepare and review qualification and validation documents, including specifications, risk analysis, plans, and reports.
  • Develop and execute test protocols for different qualification stages (DQ, IQ, OQ, PQ).
  • Coordinate with suppliers and review their documentation (FAT/SAT, technical documents).
  • Communicate effectively with qualification, customer/user, technical engineers, automation, QA, and suppliers.
  • Conduct on-site qualification activities and drive projects forward under time pressure.
Requirements
  • Completed studies in biotechnology, pharmaceutical, or process engineering, or a related field.
  • Relevant technical knowledge of current regulations in qualification and validation (GMP, ISO, 21 CFR, Annex 15, data integrity).
  • Experience in qualification/validation, preferably in the life sciences industry.
  • Fluent written and oral communication skills in English, with good German skills.
  • Proactive and independent working style, with a high level of quality awareness, efficiency, and accuracy.
What We Offer
  • A dynamic and global community of challenge seekers.
  • Opportunities for professional growth and development.
  • A comprehensive onboarding program and buddy system.
  • Flexible work arrangements, including mobile working.
  • A range of benefits, including fitness contract subsidies and catering facilities.