Qualification and Validation Engineer for Cleanroom Environments

vor 3 Wochen


Nürnberg, Bayern, Deutschland Exyte Vollzeit

About the Role:

Exyte is seeking a highly skilled Qualification and Validation Engineer to join our team in Nuremberg. As a key member of our Bio Life Sciences sector, you will be responsible for ensuring the quality and integrity of our cleanroom environments.

Key Responsibilities:

  • Implement qualification and validation activities for HVAC-, Cleanroom-, and Clean Media-Systems in accordance with current GMP regulations.
  • 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 to ensure compliance with quality standards and regulations.
  • Communicate effectively with cross-functional teams, including qualification, customer/user, technical engineers, automation, QA, and suppliers.
  • Conduct on-site qualification activities and drive 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, 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 two-day onboarding event to get you started.
  • Spacious workstations with height-adjustable desks.
  • A buddy system to help you get familiar with the team.
  • Flexible working hours to balance work and life.
  • Free coffee and water dispensers.
  • Subsidized fitness contracts with Qualitrain.

Equal Opportunities Employer: Exyte is an Equal Employment Opportunity employer, committed to equal opportunity and equal treatment.



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