In the Validation Engineer role, you will be required to support capital projects/equipment qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of equipment, systems and processes at Sanofi Ireland.
The following activities will be included as part of your role:
- Designing, executing and reporting on validation studies for equipment, systems and processes.
- Ensuring validation studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.)
- Providing technical interpretation and guidance of current US FDA and EU validation requirements for solid dose manufacture, aseptic processing, lyophilisation, sterilisation and depyrogenation
- Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times. Computerised Systems compliance would be beneficial.
- Maintaining validation documentation through the validation lifecycle
- Participation in external regulatory inspections