CSV Engineer

GenèveTemporaireChimie, Pharma, Biotechnologie2019-05-01Master / Université
We are recruiting on behalf of our client a:

CSV Engineer

Your Responsibilities

  • Develop GxP computer validation including risk assessments, traceability matrix, UFRS, actions plan and planning
  • Develop technical protocols and reports using Good Documentation Practices (GDPs)
  • Manage or execute tests validation
  • Investigate and resolve discrepancies
  • Manage periodic review of CSV
  • Complete Data Integrity reviews and subsequent remediation activities of site control systems and processes
  • Lead and/or assist with remediation activities including any potential validation activities to address identified process and/or equipment data integrity gaps
  • Compliance and adherence to all the relevant company policies, industry standards and regulatory expectations
  • Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support R&D team


Your Profile

  • A BSc/MSc Degree or equivalent experience with advanced degree
  • Experience working within a regulated environment
  • 3+ years Computer Systems Validation experience
  • Good knowledge of validation steps (especially URS, FS/DS/HDS, DQ, IQ/OQ/PQ)
  • Good knowledge of 21 CFR part 11, Eudralex Annex 11 and GAMP 5
  • Strong problem-solving skills and an ability to analyze scenarios to develop the most appropriate solution are required
  • Excellent organizational and prioritization skills
  • Ability to work well both independently and in a team environment
  • Attention to detail, flexible/adaptable, good communication, GDP
  • Completion of certified data integrity training is desirable
  • Good written and spoken command of French and English.


Votre contact

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Merci de préciser la référence JN -032019-295259

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