We are currently looking for a CSV Validation Engineer to join a leading Pharmaceutical company based in the Waterford area (Ireland) on a hybrid solution. As the CSV Validation Engineer you will be responsible for :
1.The CSV Validation Engineer will be expected to have a depth knowledge of the requirements for Computerised Systems and supporting system design.
2.Full interpretation of GAMP 5, EU GMP Annex 11 - EudraLex Volume 4 - EU guidelines to Good Manufacturing Practice
3.Products for Human and Veterinary Use, Annex 11: Computerised Systems. [21 CFR Part 11]
4.Food and Drug Administration Code of Federal Regulations - Electronic Records, Electronic Signatures, Final Rule. General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
1.A minimum of a Bachelor's Degree with a minimum of 3 years of related CSV industry experience (Pharma/Biotech).
2.Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
3.Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11 is required