Assure that all products manufactured at OEM are designed, manufactured and released according to established procedures and validated processes. Assure that all facilities, utilities and equipment involved in the production of all products manufactured at OEM complies with defined standards.
Assure the proper implementation of good quality practices in all processes at OEM and be able to identify improvement opportunities necessary to contribute to the robustness of the OEM Quality System.
Review and approval of manufacturing procedures, general procedures or instructions.
Factory acceptance Test (FAT) / Site acceptance test (SAT) execution / approval.
Provide training in validation & risk management to OEM staff to ensure that the organisation is both skilled in implementation and is utilising best in class methodologies.
Perform Quality Training to all personnel at OEM.
Ensure that validation lots are appropriately tested, reviewed and released.




Implement new procedures and instructions as a result of the observed practices on site to contribute to the Quality System robustness.
Be proactive regarding the continuous improvement in Quality processes and procedures.
Networking/Key relationships
Bachelor's degree (Licenciatura) in any related area Biotechnology, other Sciences, or related field.
Software: Fluency in Office Tools (Excel & Word), Valuable Basic knowledge in SAP.
Language: Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking).
Knowledge of Quality standards
Ability to apply a systematic approach and constant control, follow-up and verification of the results. Reflects values of Werfen in the quality of work and working relationship

📌 Validation Engineer (Barcelona)
🏢 Werfen Immunoassay
📍 Barcelona