Validation Engineer Pharma | Validierungsingenieur (m/w/d) Pharma
FERCHAU GmbH Niederlassung Saarbrücken
Job Summary
This role involves defining and implementing validation strategies across the entire product lifecycle within the pharmaceutical and life science industries. The Validation Engineer will be responsible for reviewing and enhancing the effectiveness of validation plans, monitoring key performance indicators (KPIs) across all Contract Manufacturing Organizations (CMOs), and ensuring strict adherence to GMP requirements and international standards. Key tasks include creating validation risk assessments and reviewing validation protocols. Collaboration with Research and Development (R&D) is essential to develop and adapt new product validation strategies. The ideal candidate holds a degree in Life Science or Engineering, possesses practical experience in the life science sector, and demonstrates expertise in validation techniques, US/EU regulations (EMA/FDA), and process management methodologies like Lean and Six Sigma.
Required Skills
Education
Completed degree in Life Science, Engineering, or a medical field
Experience
- Practical experience in the Life Science industry
- In-depth knowledge of relevant US and EU regulations (EMA and FDA)
- Extensive expertise in validation technology
Languages
Additional
- Not specified
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