Computerized Systems Validation (M/F)
Machine translation — original language: French.Show original
About the company
MEENT is a leading company in the life sciences field, offering solid expertise in engineering consulting and clinical research. Our commitment to innovation and quality allows us to provide tailored solutions in response to the complex challenges of our clients in the Healthcare sector.
Your tasks
In an industrial environment subject to regulatory requirements (GMP, FDA, EMA), you will work on the validation of data chains linking industrial operation lines to data management and recording systems (Data Historian, EBR).
You will contribute to ensuring the integrity, reliability, and regulatory compliance of critical data flows for production operations.
- Validation of data chains between production lines and the Data Historian system (data capture and storage).
- Validation of connections between Data Historian and EBR (Electronic Batch Record).
- Participation in EBR software configuration activities.
- In-depth analysis of regulatory and operational requirements to ensure that only relevant and essential data is transferred.
- Drafting of validation documents: protocols (IQ/OQ/PQ), reports, functional specifications.
- Analysis of data from validation tests to identify trends, anomalies, and deviations.
- Contribution to Data Integrity compliance and GMP requirements.
Requirements
- Good knowledge of Data Integrity principles (ALCOA+).
- Proficiency in SCADA, Data Historian, and EBR environments.
- Knowledge of industrial networks and communication protocols.
- Experience in Computerized Systems Validation (CSV).
- Good understanding of regulations: GMP, FDA, EMA.
- Ability to analyze technical data.
- Professional English (minimum B2 level).