Verification Engineer (f/m/d)
Posted on Jan 13, 2022 by ITech Consult
Verification Engineer (f/m/d)- technical/engineering/medical devices/compression/German
For our customer a big pharmaceutical company based in Basel we are looking for a Verification Engineer
Behind every presentation of each product sold by the company is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10000 employees worldwide. Global Technical Development (PTD) is an organization of over two thousand people globally that are integral for the mission of the company to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate of the group is, to expertly deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does. Europe Biologics (PTDE) supports biologics from Phase I into the Market. Our activities encompass process development for Drug Substance (DS) and Drug Product (DP), market formulation design and process development, device development, clinical manufacturing of DS and parenteral DPs, analytical method development, validation and release of clinical supply, development documentation submissions and transfer of development projects to commercial manufacturing.
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 (eg, pre-filled syringe, needle safety device, auto-injector, injector pen, infusion pump, new & breakthrough & platform technology, blisters, bottles, special packaging).
The Hiring Managers are looking for two verification engineers, one position is a long-term position, the other position is a temporary replacement for a maternity leave.
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, eg, for filling, assembly and packaging operations/sites, quality and regulatory departments, pharmaceutical development (eg, 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 (eg, 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 (eg, 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
It would be great if you are interested in laboratory tests for medical devices too.
Reference No.: 921000SGR
Role: Verification Engineer
Industry: Pharma Location: Basel
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert.