Validation Engineer
The validation department exists of 2 engineers, 1 technician, and 1 manager and resorts under the QRA director. The validation engineer interacts with all GMP related departments within Innogenetics.
Function
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Ensure that all systems stay within the validated status. This includes: review and approve all validation deliverables (URS, risk analysis, functional specifications, IQ OQ, PQ …), apply and/or follow-up the integration of the Innogenetics validation techniques for projects, review test results, signal deviations, and follow-up taken actions.
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Set-up, implement, and maintain procedures and templates according to GMP and quality standards in order to provide clear guidelines for validation. This includes: give advice on validation matters/issues, give training on validation procedures and documentation requirements (as well internal as external).
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Ensure timely planning and finalisation of all validation activities and projects as described in the Validation Master Plan. Follow-up the planning of validation projects. This includes: follow-up validations executed by 3rd parties, pro-active communication with departments, manage, and archive validation files, manage and maintain the validation database.
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Evaluate, analyse and approve deviations and changes in order to guarantee that these are well documented and that corrective actions are taken and followed-up. This includes: approve deviations and changes, follow-up on root cause analysis, evaluate GMP impact and need of validation or revalidation due to changes (deviations, change requests), review and approve revalidation deliverables.
Profile
- Bachelor in (bio)-engineering / Industrial Engineer
- 5 years of experience in Quality Assurance in life science or pharmaceutical environment
- Expert in cGMP (FDA, IVD) and ISO and GAMP
- User knowledge of production, utilities and QC processes
- Training skills
- Problem analysis and solving
- Persuasive
- Accuracy
- CSV experience is a plus
Contact
If you are interested in this challenging function and want to join the success of Innogenetics, please send your application letter to: jobs@innogenetics.com
Koen Mathys
Innogenetics N.V.
Technologiepark 6
9052 Zwijnaarde