CSV Engineer

SIGMAR RECRUITMENT

CORK

Leading pharmaceutical company is looking for a CSV Engineer on permanent basis . Reporting to the relevant Lead, this position will have a significant role in the validation of computerized system. 100% remote work initially but will be required onsite as time goes by. Job Responsibilities. Developing and executes all validation deliverables. Owning issues/deviations and driving them to resolution. Leading testing efforts for small to medium sized projects. Reviewing vendor protocols, test scripts, and traceability matrix. Generating test scripts to meet the user requirements. Interacting directly with project teams and the associated vendors. Assessing the validation impact of changes made to qualified instruments. Other duties as assigned. Job Skills & Experience Required. 5+ years’ experience in Bio-Pharmaceutical. Computer Science or Engineering/Science Degree is preferred. Experience working in a QC Lab Environment. A thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 / Annex 11 requirements. A thorough understanding of current industry guidance, including GAMP 5. Direct experience with computer validation and determining computer validation approach. Experience/Knowledge in qualifying DeltaV, OSI PI, Serialisation changes. Experience with HP ALM or equivalent software testing/requirements tools. For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 /marcel@sigmar.ie. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

1350 days ago