Description
Our global biopharmaceutical client requires a CSV Engineer with enterprise application experience on MES or SAP.Location: Dublin, Ireland
Start: ASAP
Duration: 12 months (likely extension)
Main responsibilities
- The role would require completion of 21 CFR 11 assessments on enterprise application (SAP or MES), creation/execution of IQ/OQ documentation, creation of SOP’s
- Participate in GMP Risk Assessments and FMEA’s, compliance review of Risk Assessment documentation
- Ensure equipment changes are implemented as per change control procedures
- Project co-ordination & communication of validation issues to team members & management
- Maintaining an up-to-date knowledge of EMA and FDA regulatory requirements
Requirements
- Degree in Engineering/Science Discipline
- Experience in computer system validation essential
- Experience in Enterprise Application (SAP or MES) essential
- Good working knowledge of Regulations and Guidelines, GAMP 5 requirements and ISPE Guidelines
- Experience in the Pharmaceutical industry
- Ability to participate in cross functional teams