**Why SimoTechWhat is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust, and excellence, we play a critical partnering role in our clients' life-changing supply of products to patients. In return, there is an excellent salary, benefits, career progression, educational support and much more.**CSV EngineerSimoTech has an opportunity for a Computer Systems Validation Engineer to join our team, supporting our client in a state-of-the-art biotechnology site in Cork. The successful candidate will have 2+ years' experience in a similar role within the life sciences industry, and will support automation projects, including CSV activities. Experience with DeltaV and PLC systems is highly desirable, with a primary focus on DeltaV automation platforms.**Key ResponsibilitiesRequirementsKey Requirements**Assist in validation of automation infrastructure systems (servers, networks, Level 2 support).Support the implementation and validation of DeltaV DCS and related automation systems.Develop and maintain validation documentation (URS, IQ, OQ, PQ, Validation Plans).Write and manage non-conformance reports and support deviation investigations.Carry out risk assessments on validation activities.Identify and resolve validation test deviations or failures.Support audits and inspections from an infrastructure validation perspective.Preparing validation summary reports.Provide support during audits and inspections from a validation perspective.Ensure work is completed in compliance with industry standards and regulations, including 21 CFR Part 11, GAMP5, and EU Annex 11.Collaborate with the Quality Assurance team to identify and amend any compliance gaps and to improve validation processes.Bachelor's Degree in Engineering, Information Systems, Computer Science or Life Sciences.Minimum of 2+ years' experience in CSV with infrastructure systems (Level 2 support experience preferred).Strong technical writing skills, especially in non-conformance and deviation reports.Familiarity with 21 CFR Part 11, EU Annex 11, GAMP5 and data integrity guidelines.****