Validation Engineer
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Job Type | Contractor |
Area | Westmeath |
Sector | Engineering |
Start Date | |
Advertiser | Ashling Guthrie |
Job Ref | 2895 |
Job Views | 952 |
- Description
- Team Horizon is seeking a Validation Engineer for our Clients Drug Product and Drug Substance manufacturing facility in the midlands for an initial 12 Month contract.
What you will be doing:
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 where required.
Identify and Imjplement Continiuos improvents inititives.
Adhere to site EHS standards and reporting requirements.
What you need to apply:
Direct Experience with hands on qualification of Steam Sterilization Autoclaves and porous loads
Understanding of the EN285 Requirements and testing
Understanding of the Saturated Steam requirements, heat transfer and Sterilization kill kinetics
Understanding of the Cycle Development and Performance requirements for the Porous Load sterilization
Understanding and handling of the Biological Indicators used for Steam Sterilization
Understanding of the SIP (Steaming/Sterilization in Place) system design and SIP CQAs
Direct Experience with hands on for SIP qualification
Understanding of the Filter Integrity Testing requirements for SIP applications
Direct Experience with hands on qualification of Depyrogenation Tunnel
Understanding of the Endotoxins and thermal Requirements for Depyrogenation cycle (dry heat)
Direct Experience with execution of Control Temperature Units and qualification requirement
Direct Experience using thermal acquisition systems.
Understanding of the Aseptic Manufacturing processes
Understanding of the Quality System Elements: Deviation, CAPA, Calibration, Preventative maintenance, Change Control