CSV Expert

vor 4 Wochen


Bern, Schweiz Consultys Vollzeit

Perform CSV activities associated with ensuring that business processes required to operate a highly automated & integrated large-scale bio-production facility are qualified and maintained in a validated stateProvide input on improvement of testing documentationSupport the implementation and adoption of the global CSV program and remediationSupport data integrity implementation and remediation for systems within the CSV programParticipate in audits and continuous improvement effortsWork with other members of IT and Site organizations to ensure that Computerized System Validation packages are consistent with validation plans and standard operating proceduresMaster's Degree or Bachelor's preferably in Computer Science, Life Sciences, Engineering, Biotechnology, Automation and10 years of experience in CSV in the Pharma or Biotech industryGreat understanding of CSV regulations such as FDA’s 21 CFR Part 11, EMA’s Annex 11Experience in modern and risk-based validation executionsBackground in Pharma/Biotech industriesDirect experience with LIMS or Laboratory systems is a plusFluency in English


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    vor 3 Monaten


    Bern, Schweiz Consultys Vollzeit

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