Senior Validation Engineer

Vor 7 Tagen

Nürnberg, Bayern, Deutschland Exyte Vollzeit

Unlock Your Potential in a Global Community of Challenge Seekers

At Exyte, we're passionate about innovation and excellence in engineering. As a Senior Validation Engineer, you'll play a crucial role in ensuring the quality and safety of our clients' facilities and equipment.

About the Role

  • Lead project-specific qualification and validation activities, adhering to current GMP regulations and industry standards.
  • Develop and review qualification and validation documents, including specifications, risk analyses, plans, and reports.
  • Prepare and execute test protocols for different qualification stages (DQ, IQ, OQ, PQ).
  • Coordinate with suppliers, review their documentation, and ensure compliance with regulatory requirements.
  • Communicate effectively with cross-functional teams, including qualification, customer/user, technical engineers, automation, QA, and suppliers.
  • Work independently on-site to coordinate and conduct qualification activities, driving 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, 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 global community of challenge seekers.
  • Opportunities for professional growth and development.
  • A collaborative and supportive work environment.
  • Flexible work arrangements, including mobile working options.
  • A comprehensive benefits package, including fitness contract subsidies.

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