Senior C&Q Engineer required for our biopharma client based in South Dublin to lead all C&Q on utilities and process equipment.
o Primarily lead all C&Q efforts relating to Utilities and Equipment.
o Support QRAES (Quality Risk Assessments) for all related Systems.
o Generate all Test Matrices for related Systems, ensure TM’s include all testing requirements and are approved and under revision control.
o Review and approval of all Vendor Documentation
o Lead for all Factory Acceptance Testing
o Liaise with vendors / suppliers in relation to GEP and GDP requirements for “leverage-able” test documentation
o Liaise with RV Lead to ensure all RV deliverables are executed as per Project Procedures.
o Generation of FV deliverables – Automation Checkout (ACO), Site Acceptance Test (SAT), Functional Testing, Phase and Recipe Testing
Education and experience required:
o A third level qualification in Science, Engineering or a relevant Quality discipline.
o 5 + years previous experience commissioning and qualification experience in utilities, BMS, process control systems and process equipment in the pharmaceutical industry.
o HVACs Systems, chilled water and formulation vessel commissioning and qualification experience preferred
o Fill finish experience is preferable
Please contact Kathy on 021 4777329 or firstname.lastname@example.org for full details of role or apply directly through this advert.