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 sectors. The Validation Engineer will be responsible for reviewing and enhancing the effectiveness of existing validation plans and monitoring key performance indicators (KPIs) across all Contract Manufacturing Organizations (CMOs). A critical component of the job is ensuring compliance with Good Manufacturing Practice (GMP) requirements and relevant US and EU regulations (EMA and FDA) through the creation of validation risk assessments and the review of validation protocols. The successful candidate will also collaborate closely with Research and Development teams to align new product validation strategies with regulatory requirements and ensure effective knowledge transfer to technical teams. This position requires strong analytical, risk-aware, and solution-oriented thinking, coupled with expertise in validation techniques and process management.
Required Skills
Education
Completed degree in Life Science, Engineering, or a medical field. Lean and Six Sigma qualifications are desirable but not mandatory.
Experience
- Professional experience in the Life Science industry
- In-depth technical knowledge of validation techniques
- In-depth knowledge of relevant US and EU regulations, EMA, and FDA
Languages
Additional
- Not specified
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