LSC have a great contract opportunity for a Validation Engineer to join a biopharmaceutical company based in Westmeath. The company is focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 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 Depyrigenation Tunnel
- Understanding of the Endotoxins and thermal Requirements for Depyrogenation cycle (dry heat)
- Direct Experience with execution of Control Temperature Units and qualification requirements
- Direct Experience using thermal acquisition systems
- Understanding of the Aseptic Manufacturing processes
- Understanding of the Quality System Elements:
- Preventative maintenance
- Change Control
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Ellen Farley at +353 214771329 at LSC on 021-4777329 if you have any more questions about this opportunity!