Cleanroom Technology Engineer

vor 3 Wochen


Nürnberg, Bayern, Deutschland Exyte Central Europe GmbH Vollzeit
Role Overview

Exyte Central Europe GmbH is seeking a highly skilled Cleanroom Technology Engineer to join our team. As a key member of our Bio Life Sciences sector, you will be responsible for handling project-specific qualification and validation activities for HVAC-, Cleanroom- & Clean Media-Systems.

Key Responsibilities
  • Prepare and review qualification & validation documents (specifications, risk analysis, plans and reports)
  • Prepare test protocols for different qualification stages (DQ, IQ, OQ, PQ) and execute them
  • Coordinate with suppliers and review their documentation (FAT/ SAT, technical documents)
  • Communicate with qualification, customer/user, technical engineers, automation, QA, and suppliers
  • Conduct on-site qualification independently and work under time pressure to drive projects forward
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, ISO14644)
  • First-hand experience in qualification/validation, ideally in the life sciences industry
  • Fluent written and oral communication skills in English and good German skills
  • Proactive and independent working style with high quality awareness, efficiency and accuracy
What We Offer
  • Onboarding event for new colleagues
  • Spacious workstations with height-adjustable desks
  • Buddy-System for familiarisation with colleagues
  • Work-life balance with mobile working possibilities
  • Catering and fitness contract subsidies


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