Qualification and Validation Specialist, Quality Control | Biologe (m/w/d)
TUTOGEN Medical GmbH
Job Summary
This 24-month fixed-term position offers a dedicated individual with a scientific background the opportunity to gain valuable practical experience within the Quality Control department of Evergen, a global leader in regenerative medicine CDMO services. The role focuses heavily on ensuring product quality through rigorous processes. Day-to-day responsibilities include the planning, organization, and execution of method development, validation activities, and equipment qualification. You will be responsible for creating and maintaining comprehensive qualification and validation documentation, utilizing statistical procedures for determining appropriate sample sizes, and contributing to process optimization efforts based on quality metrics. Candidates should possess a relevant scientific degree (preferably Biosciences, Chemistry, Pharmacy, or Medical Technology) and ideally have initial practical experience in the Pharma, Medical Device, or Biotechnology sectors. This role is ideal for applying scientific knowledge in a regulated environment while supporting audits and inspections.
Required Skills
Education
Completed Bachelor's or Master's degree in a natural science field (e.g., Biosciences, Pharmacy, Chemistry, or Medical Technology)
Experience
- Initial practical experience in the Pharmaceutical, Medical Device, or Biotechnology industry (advantageous)
- Foundational knowledge of Good Manufacturing Practice (GMP)
- Foundational knowledge of Validation and Qualification processes
- Foundational knowledge of Project Management
Languages
Additional
- 24-month fixed-term contract; Position located at the Neunkirchen am Brand site (TUTOGEN Medical GmbH)