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IVD Validation Scientist

Via Pauwels Consulting

Published on Jobat.be 6 days ago

Pauwels Consulting is a Belgian consulting firm with more than 520 experts in engineering, life sciences and IT. We offer consulting, project management and recruitment services to leading companies in Belgium and beyond. We have offices in Belgium, France, Germany and Switzerland (https://www.pauwelsconsulting.com/about/contact/) .

IVD Validation Scientist

Job description

  • Proposes validation strategies and plans for new IVD product development projects, based on product and regulatory requirements (US, CE, RoW)
  • Prepares and organizes (analytical) validation testing
  • Writes tests plans, protocols and reports for (analytical) validation
  • Collaborates with biostatistics to define statistically supported study designs
  • Assists in preparation of clinical studies in collaboration with clinical operations
  • Prepares and manages execution of alpha trials with external collaborators
  • Collaborates in writing of technical documentation for end-user purposes
  • Presents validation studies on internal and external fora
  • Assists in preparation of regulatory (pre-) submissions
  • Identifies improvement opportunities and facilitates the implementation thereof

Profile

  • Preferably PhD in Pharmaceutical, Bioscience-engineering, Biomedical, (Bio)chemistry, Biotechnology, Biology sciences or equivalent through experience
  • 3-5 years industrial experience in a similar position is required
  • Scientific and technology background in molecular diagnostics
  • Experience in IVD (development and validation studies), in a diagnostic industry setting.
  • Strong knowledge of international regulatory standards (ISO, CLSI, FDA) and experienced in GLP
  • Affinity with statistics
  • Proactive, flexible, organised and autonomous team player with strong problem solving skills
  • Excellent communicator with excellent technical writing and documentation skills

Offer

  • Uitdagende projecten op basis van uw interesses en vaardigheden 

  • Persoonlijke opvolging en duidelijke, transparante communicatie zowel voor als na aanvang van het dienstverband

  • Mogelijkheid om extra training te volgen

  • Inspirerende netwerkevenementen en legendarische drankjes na het werk

  • Sterk netwerk van toonaangevende klanten

  • Expertise binnen IT, Engineering en Life Sciences

  • Een vliegende start voor elke junior, groeimogelijkheden en mogelijkheid om verzamelde kennis te delen voor meer senior medewerkers

Mechelen - Lier

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Characteristics

Requirements

  • Master (University or Higher Education Long Type)

Offer

  • Permanent
  • Independent
  • Full-time

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