Description
New Build Biotech facility based in Dublin have a long term contract opportunity for an experienced Computer System Validation Engineer.Working on the Enterprise Applications of SAP or MES you will be required to complete the 21CFR part 11 assessments on the enterprise applications either SAP or MES creating the IQ/OQ documentation and SOP's.
Role and 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.
- 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.