LSC is seeking an experienced CSV Engineer in relation to GxP computerised systems that support manufacturing for two new innovative greenfield plants at the campus in Grange Castle Dublin
o A solid oral dose plant including API, drug product, and packaging operations all under one roof producing a capsule form for the treatment of multiple myeloma
o A cell culture biopharmaceutical clean room plant producing an injectable for the treatment of complex perianal fistulas in Crohn’s disease..
The candidate will be required to contribute to GxP risk assessments, validation strategy, write validation plans/reports, write test protocols and contribute to writing test scripts, and oversee test execution with the support of system specific subject matter experts. The role will also involve contribution to the qualification of network infrastructure.
The CSV Project Engineer will be require:
o Experience in computer systems validation, experience is required in validating interfaces between SAP and MES/LIMS, and between production/laboratory equipment and MES/LIMS.
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 GxP computerised systems (e.g. GAMP5).
o Experience in CSV strategy, planning, and execution should be greater than 5 years, depending on the relevance of the experience.
If you would like to hear more about this CSV Engineer role, the please contact Martin at LSC on 021-4777329 or apply directly through this advert.