Senior Cleanroom Technology Engineer

vor 2 Monaten


Nürnberg, Bayern, Deutschland Exyte Central Europe GmbH Vollzeit
About the Role

We are seeking a highly skilled Senior Cleanroom Technology Engineer to join our team at Exyte Central Europe GmbH. As a key member of our Bio Life Sciences sector, you will be responsible for delivering high-quality cleanroom technology solutions to our clients.

Key Responsibilities
  • Lead the design, development, and implementation of cleanroom technology systems, ensuring compliance with current GMP regulations.
  • Develop and review qualification and validation documents, including specifications, risk analysis, plans, and reports.
  • Prepare and execute test protocols for different qualification stages (DQ, IQ, OQ, PQ).
  • Coordinate with suppliers and review their documentation, ensuring adherence to technical requirements.
  • Communicate effectively with cross-functional teams, including qualification, customer/user, technical engineers, automation, QA, and suppliers.
  • Conduct on-site qualification activities, working independently under time pressure to drive project success.
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
  • A dynamic and challenging work environment with opportunities for growth and development.
  • A competitive salary and benefits package.
  • The chance to work with a global leader in design, engineering, and delivery of facilities for high-tech industries.
  • A collaborative and supportive team environment.


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