Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. We operate directly in 30 countries, and in more than 100 territories through distributors.
Our Headquarters are in Barcelona, Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded €2.2 billion in 2024, and our workforce is more than 7,000 strong.
Job Summary
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.
Key Accountabilities
- Review and approval of manufacturing procedures, general procedures or
instructions.
- Change Management: evaluate the impact of the proposed changes, approve action plan proposal and its implementation.
- Validation/ Qualification:
- Review of qualifications for facilities, equipment and utilities, including qualification strategy, execution and management of potential deviations detected.
- Factory acceptance Test (FAT) / Site acceptance test (SAT) execution / approval.
- Review of process validations, including validation strategy, execution and management of potential deviations detected.
- Be able to establish a strategy to validate changes. Review validation strategies and the corresponding documentation (protocol and report)
- Risk Assessment:
- Carry out, review and approve the risk assessment performed at OEM to evaluate the impact of changes in the final product.
- Provide training in validation & risk manag
📌 Validations Engineer (Llissá de Munt)
🏢 Actual Talent
📍 Llissá de Munt
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