Verification Engineer (50%) (m/f)

REFERENZNUMMER:

371101/29

IHRE AUFGABEN:

-Organize & conduct experimental characterization and verification of medical devices / combination products
-Evaluation, practical development and validation of new test methods & technologies
-Evaluation, implementation and management of testing equipment
-Documentation (plans, protocols, reports) according to cGMP requirements
-Liaison with and provide technical support to key customers in development, clinical and commercial phases, e.g., for filling, assembly and packaging operations/sites, quality and regulatory departments, pharmaceutical development (e.g., formulation), supply chain
-Support technology transfer of medical devices / combination products to commercial sites (specification/method/equipment transfer)

IHRE QUALIFIKATIONEN:

-Technical education, bachelor or advanced degree in Engineering or Science discipline (pharmaceutical / biomedical / materials science or a related field)
-Experience in practical testing and characterization of medical devices/combination products, primary packaging or pharmaceutical development (e.g., formulation, analytics), preferably for parenteral drug products
-Experience of working in pharma or other closely-regulated environment under cGMP or similar working practices
-Appropriate knowledge of legislation, regulation, industry standards and guidance around the area of medical devices / combination products
-Hands on expertise in: Functional / physical testing (e.g., container closure integrity, compression / tensile testing), Dimensional measurements, Jigs & fixture design
-Good knowledge of statistical techniques, risk management, root cause analysis is a plus
-Good command of spoken/written English and German

WEITERE QUALIFIKATIONEN:

Quality manager, Qualification/validation specialist