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Validation Engineer


Requisition Number: N/A

Region: Europe
Country: Czech Republic
City: Trhové Sviny

Responsibilities

  • Plan, coordinate, execute and monitor design verification and
    validation testing to directly support the verification and validation master
    plan
  • Approve NPI validation documents and other quality documents
    related to NPI project
  • Guide and manage validation executions and associated tests to be performed in the NPI phase and in close collaboration with other related/relevant functions
  • Draft and maintain validation plans and requirements
  • Authority to create, review and approve validation documentation
  • Ensure that all project related documents are created and well managed according to the regulations, customer specifications and internal quality standards within validation processes

Qualifications - Education & Experience

  • Applicable technical or academic degree, e.g. BSc or MSc in Engineering,
    Plastic Technology or equivalent knowledge and skills (the FDA requires
    validation training by an outside entity no later than 6 months from job start
    date)
  • Minimum 5 year’ experience of validation and/or quality in
    contract manufacturing industry with international customers

Qualifications - Skills & Competencies

  • Understanding of Plastics materials basics, the construction
    and technologies of injection moulding tools and automation
  • Understanding of New Product Introduction and plastics
    processing knowledge
  • Ability to understand interfaces between organizations
    and processes incl. SOP's
  • Ability to form a clear overview of responsible area
    while paying attention to detail. Detecting causal connections between
    tasks, schedules and details
  • Strong teamwork, collaboration and team leadership skills

If you are interested in this position please send your CV and application to Lenka Podroužková - HR Manager, Trhové Sviny.
E-mail: lenka.podrouzkova@phillipsmedisize.com

 


 

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