Senior 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.

1250 days ago