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MIMiltenyi Biotec

Qualification Validation Expert(m/w/x)

Bergisch Gladbach
Full-timeWith Home OfficeExperienced

Qualifying and validating production, QC, and logistics systems for biomedical tech. GMP and FDA guideline familiarity required. Flexible remote work, international teams.

Requirements

  • Degree in life sciences, engineering, or comparable technical field, or similar qualification
  • Familiarity with GMP and FDA guidelines
  • Hands-on experience qualifying systems in regulated environments (pharmaceutical industry or similar)
  • Ability to bring structure to dynamic environments
  • Initiative in process improvement
  • Team player with open communication skills
  • Fluent English
  • Comfortable collaborating across functions and cultures

Tasks

  • Support transition from clinical to commercial manufacturing
  • Ensure compliance with GMP standards
  • Plan and execute qualification and validation
  • Manage lifecycle of production, quality control, and logistics systems
  • Prepare and maintain qualification and validation documentation
  • Advise on qualification and validation projects
  • Propose and implement pragmatic solutions
  • Contribute to GxP activities
  • Enhance qualification and validation processes
  • Collaborate with internal and external stakeholders
  • Conduct training sessions for knowledge transfer

Work Experience

  • approx. 1 - 4 years

Education

  • Vocational certificationOR
  • Bachelor's degree

Languages

  • EnglishFluent

Benefits

Flexible Working

  • Flexible and remote work

Informal Culture

  • International teams
  • Cross-border intercultural communication
  • Room for creativity

Healthcare & Fitness

  • Corporate sports activities
  • Health provision

Learning & Development

  • In-house Training Academy
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Miltenyi Biotec and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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