Description
We are looking for a
Medical Device Verification Engineer / Technician (m/f)
Reference: -en
Start: 10/15
Duration: 12 MM
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Evaluation, selection, design, development, characterization, industrialization of and interaction with medical devices for combination products (pre-filled syringe, needle safety device, auto injector, injector pen, infusion pump, new technology, special packaging)
- Practical evaluation of new and breakthrough technologies, development of new test methods
- Implementation and qualification/validation of new lab testing equipment
- Draw up of plans, protocols, reports as required in GMP facilities
- Organise test in the areas of experimental development, verification, complaint investigation and change evaluation
- Provide technical support to key customers in clinical and commercial phases (filling, packaging operations, regulatory, supply chain)
- Support the technology transfer of combination products and medical devices into commercial facilities/packaging centres (specification/method/equipment transfer)
Your qualifications
- Technical education, preferably with an engineering degree
- Track record and experience in practical testing and characterisation of medical devices, special/innovative packaging
- Experience in working in the pharma industry under cGxP or similar working practices
- Sound knowledge regarding combination products and medical devices
- Demonstrable practical knowledge of the drug container integrity, parenteral drug delivery (sub-cutaneous, intra-venous, intra-muscular, transdermal)
- Basic experience in statistical techniques and risk assessment, instrument calibration, equipment qualification, functional testing and reliability, secondary packaging, transport studies and validation
- Excellent command of verbal/written German and English
- Excellent documentation skills under cGxP requirements
- Excellent team player
- Excellent IT knowledge (Zwick TestXpert II)
Skills:
- Qualification/validation specialist
Keywords: Spezialist Validierung Qualifizierung