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Qualification Validation Expert(m/w/x)
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
- English – Fluent
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
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Qualification Validation Expert(m/w/x)
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
- English – Fluent
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
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Miltenyi Biotec
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt einzigartige Lösungen für die biomedizinische Spitzenforschung sowie neuartige Zell- und Gentherapien.
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