CSV Engineer 1701
On-siteDublin, Leinster, Ireland
Job Summary
Author and manage C&Q plans, PCS automation validation plans, URS, FAT, and IOQ documentation in collaboration with cross-functional teams. Monitor FAT and IOQ execution, resolve protocol issues, and execute CSV-related tests on lines and equipment. Ensure automation deliverables comply with regulations and industry best practices, maintaining traceability across C&Q plans, automation plans, and summary reports. Develop templates for SDLC deliverables including requirements specifications, RTMs, and test scripts. Conduct system walkdowns to verify technical documentation and identify risks to improve qualification strategies. This role supports validation for a Drug Product Facility project for a biopharmaceutical client in Co. Dublin.
Required Qualifications
- Bachelor's degree in Engineering, Computer Science, Life Sciences or similar
- Minimum 6 years' experience in GMP and validation disciplines
- Strong understanding of pharmaceutical design, build, commissioning, & validation processes
- Understanding of alignment with EU and US FDA regulatory requirements
- Knowledge of regulatory compliance such as 21 CFR Part 11, Eudralex Annex 11, and GAMP 5
- Solid technical understanding of computer systems and PLC automation systems
- Experience working with one or more of the following systems: MES, PI Data Historian, PCS, Lab systems, QBMS, or inspection line control systems
Desired Qualifications
- Experience working with paperless validation systems (Kneat)
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