




**Job Description** --------------------- • Perform activities related to Thermal Qualification, Equipment Qualification, Thermal Box Qualification, Process and Computerized System Validation; • Prepare validation documents related to the activities described above, such as Protocols, Plans, Risk Assessments, and Reports; • Analyze validation deviations and propose corrective actions; • Perform Thermal Qualification tests, Operational Equipment Qualification tests, and Process Validation tests; • Discuss results of conducted studies, prepare indicators, trend reports, and other applicable analyses; • Manage execution of tests performed by third-party companies, where applicable; • Manage Qualification/Validation activities, ensuring adherence to deadlines; • Manage Calibration activities; • Calibrate instruments; • Develop and manage Change Controls; • Develop CAPAs, conduct investigations, and propose actions; • Manage Validation Documentation within the Quality Management System; • Deliver training on validation procedures and work instructions; • Participate in projects. **Requirements** -------------- Academic Qualification: Completed Bachelor’s degree. Experience/Knowledge in the role: Experience in validation activities. Foreign languages: English (desirable). Training: As per Training Matrix. Skills: Numerical skills and oral/written communication; Microsoft Office suite; negotiation, interpersonal relationships, and teamwork; Advanced Excel (desirable). **Responsibilities** --------------------- 1. Prepare validation documents, such as: User Requirement Specifications (URS); facilitation and documentation of risk assessment meetings; validation plans, protocols, periodic reviews, test reports, and final reports; 2. Perform Thermal, Process, Equipment, and System Qualification/Validation tests; 3. Document validation deviations, assess their impact on the validation process, and propose corrective actions; 4. Draft Standard Operating Procedures (SOPs) and Work Instructions (WIs); 5. Deliver and support training; 6. Review and approve equipment calibration and validation; 7. Review and approve process validation; 8. Participate in project “start-up” phases; 9. Develop and analyze performance indicators (KPIs), where applicable; 10. Review and approve process validation; 11. Comply with HSE, Quality, and Code of Conduct requirements.


