Validation Engineer | Validierungsingenieur (m/w/d)
FERCHAU GmbH Niederlassung Dresden
Job Summary
This role involves ensuring the quality and compliance of production processes for a material specialist operating in the medical and environmental technology sectors, specifically at a new plant in Kleve, Germany. The Validation Engineer will be responsible for executing daily batch releases and leading the validation and qualification of new production lines, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Key duties include developing new production processes, managing all validation activities like software validation and thermal mapping, and maintaining comprehensive GMP-relevant documentation, such as SOPs and validation protocols. The ideal candidate will have a degree in Bioengineering or a comparable technical field, possess hands-on experience in a GMP-regulated environment (ideally Medical Devices or Pharma), and demonstrate strong organizational skills, supported by good written and spoken English proficiency.
Required Skills
Education
Completed university degree, e.g., in Bioengineering or comparable technical training
Experience
- Professional experience in a GMP-regulated environment (e.g., Quality Management, Food, Pharma, or Medical Devices)
- Experience in planning and executing validation activities
- Experience in technical documentation and scientific work
Languages
Additional
- Not specified
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