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CQV/Qualification Engineer

vor 2 Wochen


Dortmund, Nordrhein-Westfalen, Deutschland 275c726a-f773-449e-951f-0aa369aa2f98 Vollzeit 60.000 € - 90.000 € pro Jahr

CQV/Qualification Engineer - Dortmund, Germany - 2-3 Months Initial Contract
This innovative organisation is a global leader in the development and manufacturing of high-quality sterile injectable products, offering solutions tailored to meet the needs of both clinical and commercial markets. With a strong focus on cutting-edge technologies, they are actively driving advancements in drug substance manufacturing. Notably, their current project in Germany is centred around implementing single-use technology, which enhances efficiency and flexibility in the production process.

What You'll Do

  • Develop and execute qualification documents including URS, risk assessments, IQ/OQ protocols, reports, and supporting documentation.
  • Collaborate with stakeholders to ensure timely review and approval of documentation.
  • Report progress, manage timelines, and ensure alignment with project milestones.

What you'll need:

  • Extensive experience in CQV/qualification engineering within the biopharmaceutical industry.
  • Proven track record qualifying equipment such as bioreactors, ultra-filtration, chromatography, and related systems.
  • Strong knowledge of GMP, regulatory requirements, and risk management principles.
  • Fluent German speaker (mandatory).

If this role is of interest to you, please apply now