For our customer in the Pharmaceutical industry we are looking for a:
In the Device and Packaging Development Department, we are responsible for the development of medical devices, combination products and packaging systems for R&D portfolio drug products. Our activities comprise a wide range of engineering disciplines ranging from the initial definition of product requirements to first commercialization and subsequent product care considering required regulatory, legislative, ecological, economical and technical aspects. Within the department, the Section Verification Engineering is responsible for the generation and management of experimental and cGMP verification and qualification activities providing objective evidence that the medical device/combination products/packaging system perform according to patient and technical needs. Thereby, we support the evaluation, selection, design, development, characterization, and industrialization of medical devices, combination products and packaging systems (e.g., pre-filled syringe, needle safety device, auto-injector, injector pen, infusion pump, new & breakthrough & platform technology, blisters, bottles, special packaging).
Tasks & Responsibilities
- 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)
- Technical education, bachelor or advanced degree in Engineering or Science discipline (pharmaceutical / biomedical / materials science or a related field)
- At least 2-3 years 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
- Start date: asap
- latest Start Date: 01.03.2022
- End date: One year
- Workplace: Basel
- Workload: 80-100%
- Home Office: possible, due to corona. Onsitework required.
Please apply online. For further information about the position, please contact your Kelly recruiter, Franck Maerky (+41 61 270 80 17).