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Method Validation Engineer (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Engineering, Engineer
Projektbeschreibung
REFERENZNUMMER:
251652/11
IHRE AUFGABEN:
-Development of a new testing method
-Roll-out the statistical assessment required for method validation
-Provide technical and statistical know-how to ensure validation and transfer to production site of new testing method
-Follow GMP and cGMP requirements for testing laboratory
-Participate in teams to assist in the realisation of necessary improvements to process related issues
IHRE QUALIFIKATIONEN:
-MSc in mechanical engineering or any in other related field
-Experience in development of medical devices and/or combination products
-Experience in development and validating physical test method
-Deep knowledge of statistical tools used for method validation and transfer such hypothesis tests, sample sizing, normality check, GR&R
-Knowledge of ISO 13485, FDA CRF 21 Part 820, GMP and cGMP
WEITERE QUALIFIKATIONEN:
Qualification/validation specialist
251652/11
IHRE AUFGABEN:
-Development of a new testing method
-Roll-out the statistical assessment required for method validation
-Provide technical and statistical know-how to ensure validation and transfer to production site of new testing method
-Follow GMP and cGMP requirements for testing laboratory
-Participate in teams to assist in the realisation of necessary improvements to process related issues
IHRE QUALIFIKATIONEN:
-MSc in mechanical engineering or any in other related field
-Experience in development of medical devices and/or combination products
-Experience in development and validating physical test method
-Deep knowledge of statistical tools used for method validation and transfer such hypothesis tests, sample sizing, normality check, GR&R
-Knowledge of ISO 13485, FDA CRF 21 Part 820, GMP and cGMP
WEITERE QUALIFIKATIONEN:
Qualification/validation specialist
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik
Hays
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Straße:
Willy-Brandt-Platz 1-3
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Ort:
68161 Mannheim, Universitätsstadt, Deutschland