Description
CSV Engineer supporting the existing lab facility of a global biotech organisation, based near Dublin. The validation engineer will be responsible for the completion of 21 CFR 11 assessments on lab equipment, creation/execution of IQ/OQ documentation, creation of SOP's.Role and Responsibilities:
- The role would require completion of 21 CFR 11 assessments on lab equipment, creation/execution of IQ/OQ documentation, creation of SOP's.
- Projects will include supporting the qualification of plant computer systems such as Delta V, new plant equipment and also up-grades to existing computer systems and equipment
- Quality review and approval of Equipment Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, PQ protocols.
- 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.
- Labs systems experience 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.