Senior Computer System Validation (CSV) Engineer

Job Title : Senior Computer System Validation (CSV) Engineer

Location :Wilmington, DE

JD :

Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelor’s in Pharmacy
Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system
Knowledge, Experience and Skills:
{
CORE CSV
 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes
 Authoring of URS/FS, protocols, final reports, validation plan/report
 High-level understanding of Veeva Vault suits
 Risk-based testing aligned to CSA fundamentals
}
AND
{
R&D
 High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP