Innogenetics wants to strengthen its Platform development department with an
Instrument & Software Test & Validation Engineer
Innogenetics is an international biopharmaceutical company, based in Ghent.
Its Diagnostics unit applies its research and know-how in molecular biology, immunology, and virology to build a business of specialty diagnostics products in the areas of infectious diseases, neuro degeneration and genetic testing.
The job
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You are responsible for consistent and traceable documentation of instrument & software products according to regulatory (FDA, CE, ISO) and company standards in order to be able to release the instrument & software for sale in regulated countries.
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You are responsible for the structured testing and validating of new system releases (including software and instrument), guaranteeing full traceability with the specifications, in order to obtain qualitative systems conform to market and regulatory requirements (functional and qualitative). This by defining and executing validation plans and protocols, performing problem solving, risk evaluation and issue management, motivated with scientific and statistical rationales,
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By actively participating in brainstorm sessions with R&D, product managers and application developers, and by executing functional analysis of new projects you define and investigate functional solutions for new projects, meeting company and market needs in order to contribute actively to the extension/improvement of the delivered system to internal and external customers.
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You organise internal and external software production in order to guarantee the application of all defined procedures for production, QC and release.
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You develop the end-user documentation and design training tools to train internal and external users in the optimal use of the software.
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You investigate regulatory and company standards and define procedures in order to control the design and guarantee a product that can withstand audits from regulatory authorities.
Profile
- University degree
- Minimum 5 years of experience (multidisciplinary : IT, bio-tech, regulatory, statistics, …)
- Insight in software application architecture.
- Good documentation skills.(Office tools, RoboHelp)
- Affinity and experience with the use of diagnostic laboratory instrumentation
- Experience with structured SW testing (e.g. TMap)
- English/Dutch
- Customer oriented
- Creative and innovative
- Team player : open minded, cooperative, takes initiative
- Good written and oral communication skills
- Organised, accurate, practical
We welcome your application and the possibility to evaluate your curriculum!
Innogenetics
Koen Mathys
Technologiepark 6
9052 Zwijnaarde
Tel : 09 329 13 14
Moblile: 0472 799 713
E-mail : koen_mathys@innogenetics.com