Validation Engineer Role Athlone, Westmeath

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?

1. Understanding of the ASTM E2500 Qualification Requirements
2. Understanding of the system/equipment qualification lifecycle: URS to Operational phase
3. Direct Experience with hands on execution of System/equipment Mechanical Completion, Installation Verification and Functional Verification Testing
4. Understanding of the Quality Risk Management within qualification requirements
5. Understanding of manufacturing equipment used in Biologics and Drug Product Processes
6. Understanding of the Utilities Systems and systems and their CQAs (Clean Steam, WFI, HVAC, process gasses)
7. Understanding of the Aseptic and Biologics Manufacturing processes and contamination control
8. Understanding of the BMS systems and Automation architecture
9. Understanding of the ASME BPE - Bioprocessing Equipment Requirements
10. Understanding of the Quality System Elements:
    1. Deviation
    2. CAPA
    3. Calibration
    4. Preventative maintenance
    5. 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!