Aktuelle Jobs im Zusammenhang mit Cleanroom Technology Engineer - Nürnberg, Bayern - Exyte


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Cleanroom Technology Engineer

vor 2 Monaten


Nürnberg, Bayern, Deutschland Exyte Vollzeit

Unlock Your Ambition

At Exyte, we're driven by a shared vision of innovation and excellence. As a Cleanroom Technology Engineer, you'll be part of a global community of challenge seekers who are passionate about shaping the future of high-tech industries.

About the Role

We're seeking a highly skilled and motivated individual to join our team as a Cleanroom Technology Engineer. In this role, you'll be responsible for handling project-specific qualification and validation activities, ensuring compliance with current GMP regulations for HVAC-, Cleanroom- & Clean Media-Systems.

Key Responsibilities

  • Prepare and review qualification & 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 independently, working under time pressure to drive projects forward.

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, ISO14644).
  • 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

As a Cleanroom Technology Engineer at Exyte, you'll have the opportunity to work on exciting projects, collaborate with a global team, and contribute to the company's mission of shaping the future of high-tech industries.