We’re seeking a CSV Engineer for an exciting and challenging position! Join us at Qualitest! This is a full-time, hybrid position located in The Sharon area In this position you will: * Write Computerized systems validation documents and test protocols: IQ,OQ,PQ * Write Computerized systems design and summary documents: URS,FRS,VP,VSR * Write software applications reject lists, bug identification, report and monitoring. * Functional and detailed documented testing of life-science computerized systems.
- Comply with healthcare regulation for computerized systems ( 2CFRPART11, CE Annex 11) * BS.c in the life science disciplines (Chemistry, Biothecnology, Biology, Biomedical Engineering, etc.) * Working experience in analitical labs and QC * Experience in computerized system validation in the life science industry( Biotech, Pharma, Medical Device etc.) * Experience with Serialization processes- MUST * Experience with software testing specifically and\or familiar with IT technical issues.
