Packaging Engineering Specialist (m/f)

REFERENZNUMMER:

272481/11

IHRE AUFGABEN:

-Compilation of relevant documentation for the production transfer of sterile barrier packaging solutions (blisters and pouches with Tyvek) according to global standards like ISO 11607, GMP standards and FDA requirements
-Development of qualification and validation protocols/reports for packaging and shipping qualification activities
-Application of theories and concepts within the area of packaging development to independently manage activities related to the development and implementation of this packaging technology
-QbD and DOE
-Risk management
-Working under guidance with general instructions on new assignments

IHRE QUALIFIKATIONEN:

-Engineering degree, preferably in packaging, material science or a related field
-Experience in sterile barrier packaging solutions (Tyvek(TM))
-Experience in secondary and tertiary packaging development or packaging
-Statistical knowledge including DOE and QbD, statistical software such as Minitab
-Knowledge regarding design control, documentation, risk management and processes such as MRD, DIR, FMEA, Design Verification, and URS commercial drug products or combination products
-English skills are essential, German skills are beneficial

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist