Company : Sotera Health Location : From : Talent BE
2. Handle periodic customer requalification’s (protocol and report edition).
3. Organize the execution of validation protocols and technically driven customer and/or EAS projects, which include but are not limited to the following:
? Planning all validation activities, project runs, ancillary resources, lab testing and sample handling, in order to minimize the risk of errors in the execution, ? Cycle programming and preparation of necessary process documents (CSA) and safety assessments, ? Microbiological samples inventory, ? Data collection and analysis (if applicable), ? Assuring proper handling, storage and shipping of bioburden, LAL, biological indicators, sterility, engineering or residual samples to the appropriate laboratory.
4. Ensure validation activities are carried out according to the agreed time-schedule and communicate follow up to relevant persons (validation manager, EAS, sales, etc); 5. Organize work of validation operators for load preparation in collaboration with the validation team leader.
6. Writes validation work instructions for production staff and the lab.
Make sure it complies with protocol requirements.
This includes but is not limited to ? Creation of validation batch ? Lab work requests with all relevant information required to perform laboratory analyses and related purchase orders edition 7. Responsible for annual equipment re-commissioning (sterilization and laboratory); 8. Update validation status in the relevant systems; 9. Maintain the quality and integrity of information required for validation records.
Report any deviation to validation manager.
10. Provide support to Maintenance or Engineering department in the performance of IQ/OQ/PQ activities of new or existing facility equipment.
Authority:
The ValidationEngineer reports to the Validation Manager.
Requirements:
Knowledge/Education and Training:
? Industrial Engineer or equivalent ? Modern Quality Systems & standards ? ISO, FDA, GMP Experience:
? First experience in the industry is useful ? Project management ? First experience in writing and executing validation protocols ? Fluent in English and French (reading, speaking, writing) Skills:
? Fine organizational skills ? Efficient, accurate, work according to plan ? Strong computer skills ? Relevant standards knowledge Contacts:
