Technician, Facility Engineering
2 giorni fa
The Technician Facility Engineering & Site Services possesses technical skills to assess the operational status of systems, equipment, and facilities used in the production processes within the Cell Factory. They are also familiar with the general principles of GMP regulations and the site's quality system procedures relevant to their role.
The Site Services Operator is responsible for:
- Understanding all current general and specific documentation required to perform their duties
- Carrying out assigned tasks independently and professionally to verify the operational status of systems, equipment, and facilities, ensuring compliance with the GMP Production System
- Checking the proper functioning of systems, equipment, and facilities
- Managing SCADA alarms and coordinating with the QA department
- Supporting QA in handling deviations, CAPAs, and changes
- Performing or assisting in maintenance activities on systems, equipment, and facilities
- Contributing constructively to work planning and organization
- Promptly reporting any deviations or alarms to QA and their supervisor, and suggesting improvement actions
- Overseeing equipment qualification activities and ensuring that the qualification status of the facility is achieved and maintained
- Assisting in the management of maintenance, calibration, and qualification/requalification plans for systems and equipment
- Drafting and revising SOPs and Working Instructions related to systems, equipment, and facilities, and proposing modifications or improvements
- Properly archiving all maintenance-related documentation
- Assisting new personnel in performing technical activities
- Maintaining a constant level of professional development and training
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