Validation Engineer and Computer Systems Specialist
il y a 4 semaines
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.
About the Role
As a Validation Engineer and Computer Systems Specialist, you will be responsible for:
- Writing the validation master plan (POS or VMP)
- Participating in risk analyses
- Establishing and monitoring the validation schedule
- Identifying and monitoring key users
- Writing URS, test sheets, and defining user needs
- Writing qualification protocols, running IQ/OQ/QP tests, and writing qualification reports
- Being 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
- Drafting and monitoring documents related to validation processes (protocols, procedures, reports, etc.)
About You
We are looking for a candidate with a master's degree and knowledge of the pharmaceutical industry processes in the field of validation of computerized systems. Your 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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