Validation Engineer and Computer Systems Specialist

il y a 4 semaines


Lyon, Auvergne-Rhône-Alpes, France Audensiel Temps plein

Validation Engineer and Computer Systems Specialist

Audensiel is seeking a skilled Validation Engineer and Computer Systems Specialist to join its team. As a key member of our digital transformation team, you will be responsible for ensuring the validation of computerized systems in the pharmaceutical industry.

Key Responsibilities:

  • Develop and implement validation master plans (POS or VMP)
  • Participate in risk analyses and establish and monitor validation schedules
  • Identify and monitor key users and write URS, test sheets, and define user needs
  • Write qualification protocols, run IQ/OQ/QP tests, and write qualification reports
  • Be comfortable with the validation of one/more of the following tools: Excel files, software (SAP, Trackwise, etc.), CRM, laboratory equipment, or production with human-machine interface (HMI) type automata
  • Draft and monitor documents related to validation processes (protocols, procedures, reports, etc.)

Requirements:

  • Master's degree in a relevant field
  • Knowledge of pharmaceutical industry processes in the field of validation of computerized systems
  • Rigor and sense of relationship are essential assets for this position

Audensiel is committed to fighting discrimination and promoting diversity and equal opportunities.



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