LSC have a requirement for an experienced CSV Engineer for the validation of the GxP computerised systems that support a new manufacturing facility being constructed on a a greenfield site based in Grange Castle, Dublin.
This is an exciting & challenging opportunity for the right candidate to contribute from the start in building computerised solutions to support manufacturing in new facilities, both giving of their experience but also growing and developing their project & technical skillset in collaboration with the client team and vendor consultants.
In this role you will be responsible for valldation input on a range of computerised systems associated with the new faciility. The main focus of the role will be validation of a Manufacturing Execution System (PAS-X V3.7/8 MES) and Laboratory Information Management System (Labware LIMS v6).
You will be required to contribute to validation strategy, write validation plans/reports, write test protocols and contribute to writing test scripts, and contribute to test execution with the support of system specific subject matter experts.
As CSV Engineer you will have the following experience:
o CSV experience validating interfaces between SAP and MES/LIMS, and between production/ laboratory equipment and MES/LIMS.
o Experience in CSV strategy, planning, and execution should be greater than 5 years, depending on the relevance of the experience.
o The candidate must demonstrate strong practical understanding of electronic records and signatures regulations (e.g. FDA 21.CFR.Part 11 and EU Annex 11), prevailing regulatory guidelines (e.g. Data Integrity guidelines), and good practice for computerised systems (e.g. GAMP5).
o Experience in Pharmaceutical processes and environments is necessary. Experience in the following processes is an advantage: API, tabletting, primary/secondary packaging, and clean room biotechnology environments.
For full details on this role please contact Antointette at 021 4777329 or email@example.com or apply directly through this advert.