Validation Engineer Cavan

Validation Engineer, Validation Specialist,

Senior Validation Engineer required to Manage the computer system Validation process for the overall site, Manage GxP Risk Management process and ensure that appropriate mitigation steps are implemented to meet current GxP regulations

The program of work is of key strategic importance to the business and there are three key deliverables within this program

Enterprise resource planning business system (ERP) proposed SAP Business 1 with BEAS add on modules.
QC Empower laboratory chromatography data management system. CDS.
Retrospective validation/Gap analysis of all other potential GxP computer systems on site.

Skills / Experience:

3 – 5 years in a Computerized Systems Validation role (CSV).
Excellent technical English verbal and written skills
CSV experience in an established QA/IT function preferably in the pharmaceutical/healthcare industry
Strong knowledge of GAMP5, CSV, Project Life Cycle and GxP Regulations
Experience drafting, reviewing and/or approving validation documentation VMP, URS, RA, IQ, OQ, PQ, UAT, SAT and VSRs.
Previous experience generating Risk Assessment Matrices for validation projects.
Experience in validating pharmaceutical CDS and ERP system computer/control systems a distinct advantage.
Excellent attention to detail, self-motivated and ability to work to tight or changing deadlines
Work with existing in-house validation team