- Lead Development and execution of CD and PQ requirements for new projects.
- Develop and execute Requal protocols for various Thermal
Systems (Autoclave, SIP, CTUs)
- Lead investigations on validation deviations
- Identify and Implement Continiuos improvents inititives.
- Adhere to site EHS standards and reporting requirements.
competences and qualifications:
Experience with hands on qualification of Steam Sterilization Autoclaves and
of the EN285 Requirements and testing
of the Saturated Steam requirements, heat transfer and Sterilization kill
of the Cycle Development and Performance requirements for the Porous Load
and handling of the Biological Indicators used for Steam Sterilization
of the SIP (Steaming/Sterilization in Place) system design and SIP CQAs
Experience with hands on for SIP qualification
of the Filter Integrity Testing requirements for SIP applications
9. Direct Experience
with hands on qualification of Depyrigenation Tunnel
Understanding of the Endotoxins and thermal Requirements for Depyrogenation
cycle (dry heat)
Experience with execution of Control Temperature Units and qualification
Experience using thermal acquisition systems
Understanding of the Aseptic Manufacturing processes
Understanding of the Quality System Elements: