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 ASTM E2500 Qualification Requirements
- Understanding of the system/equipment qualification lifecycle: URS to Operational phase
- Direct Experience with hands on execution of System/equipment Mechanical Completion, Installation Verification and Functional Verification Testing
- Understanding of the Quality Risk Management within qualification requirements
- Understanding of manufacturing equipment used in Biologics and Drug Product Processes
- Understanding of the Utilities Systems and systems and their CQAs (Clean Steam, WFI, HVAC, process gasses)
- Understanding of the Aseptic and Biologics Manufacturing processes and contamination control
- Understanding of the BMS systems and Automation architecture
- Understanding of the ASME BPE - Bioprocessing Equipment Requirements
- 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!