Lead Engineer Qualification Specialist

Vor 6 Tagen


Stuttgart, Baden-Württemberg, Deutschland Exyte Vollzeit

Unlock Your Potential as a Lead Engineer Qualification Specialist

At Exyte, we're committed to delivering exceptional results in the high-tech industry. As a Lead Engineer Qualification Specialist, you'll play a crucial role in ensuring the quality and integrity of our facilities and equipment.

About the Role

  • Lead project-specific qualification and validation activities in accordance with current GMP regulations.
  • Develop and review qualification and validation documents, including specifications, risk analyses, plans, and reports.
  • Prepare and execute test protocols for various 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, and report to the CQV manager/project management.
  • Work independently on-site to coordinate and conduct qualification activities under time pressure.

Requirements

  • Completed studies in biotechnology, pharmaceutical, or process engineering, medical devices, or a related field.
  • Relevant technical knowledge of current regulations in qualification and validation (GMP, ISO, 21 CFR, Annex 15, data integrity).
  • Previous experience in qualification/validation, ideally 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 challenging work environment.
  • Opportunities for professional growth and development.
  • A competitive compensation package.
  • A comprehensive benefits program.
  • A collaborative and supportive team environment.


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