This organization is focused on Gene Therapy to treat immunological diseases. Gene Therapy uses genes to treat diseases by deleting, adding or altering DNA, this way it targets the root cause of the problem instead of just treating the symptoms. This firm uses viruses and vectors to get into the cell to deliver the new copy of the gene into a cell.
As a Validation Engineer you will ensure that all systems are in place, this includes planning systems, documentation systems, and Facility Monitoring systems. You will also coordinate repair and troubleshooting activities on corporate machinery and equipment. You will also advice the Head of Manufacturing on equipment risks and develop and execute plans to mitigate these risks.
- Coordinating and executing preventive and corrective maintenance of equipment, including GMP reporting of maintenance and calibration activities
- Setting up adequate maintenance and calibration documentation systems and keeping these systems updated according GMP guidelines.
- Keeping a planning system in place for maintenance and calibration activities. Develop planning efficiencies by setting up maintenance periods.
- Commissioning and changing equipment and utilities in collaboration with the Head of Manufacturing
- Being able to write product life cycle documentation, such as validation protocols and reports and execute accordingly.
- Coordinate in-depth, complex trouble shooting on equipment
- HTS level or equivalent by training or experience
- Experience with setting up maintenance and calibration documentation and planning systems
- Experience with maintenance and calibration activities in a pharmaceutical/GMP environment
- Preferably experience with maintenance and (re)qualification of utilities used in pharmaceutical production environments, such as water and air treatment systems
- Proficient in English, both in oral and written communication
For more information please contact Carla Garcia at email@example.com or +31 (0) 20 658 98 01.