Description
For our client in the pharmaceutical industry, we are looking for a
Verification Engineer (50%) (m/f)
Reference: -en
Start: asap
Duration: 12 MM
Place: Basel Stadt
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- 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)
Your qualifications
- 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
Skills:
- Qualification/validation specialist
- Quality manager
Keywords: Technical education, bachelor, advanced degree, Engineering, Science, pharmaceutical, biomedical, materials science, practical testing, characterization of medical devices, combination products, primary packaging, pharmaceutical development, formulation, analytics, parenteral drug products, pharma, cGMP, regulated environment, functional testing, physical testing, container closure integrity, compression testing, tensile testing, dimensional measurements, Jigs & fixture design, statistical techniques, risk management, root cause analysis, Englisch, Deutsch