FULL TIME
Limerick
Réalta Technologies seeks an experienced DeltaV CSV Engineer to support our client, a leading biotechnology manufacturer based in Limerick. The successful candidate will be responsible for the validation and compliance of automation and control systems, ensuring they meet regulatory, operational, and quality standards within a GMP-regulated environment.
Job Responsibilities
* Plan, develop, and execute CSV documentation including validation plans, risk assessments, test scripts (IQ/OQ/PQ), and summary reports for automation systems.
* Lead validation activities for DeltaV distributed control systems (DCS) and associated equipment, ensuring full compliance with GAMP 5 and site validation procedures.
* Support validation of other automation and control platforms such as PLCs, SCADA, and data historians.
* Collaborate with automation, QA, and IT teams to ensure validated state is maintained through system lifecycle management, change control, and deviation processes.
* Ensure all CSV deliverables meet data integrity, Part 11, and Annex 11 regulatory expectations.
* Provide technical input during project design and commissioning phases, ensuring validation is embedded early in the system lifecycle.
* Participate in audits and regulatory inspections, providing subject matter expertise on validated automation systems.
Job Requirements
* Bachelor's degree in Engineering, Computer Science, or related discipline.
* Minimum 5 years of CSV experience in the biopharmaceutical or biotechnology industry.
* Proven hands-on experience with DeltaV DCS systems and familiarity with other automation platforms (e.g., Siemens, Allen-Bradley, Rockwell, SCADA).
* Strong understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and GMP regulations.
* Demonstrated ability to develop and execute validation documentation for complex automation systems.
* Excellent communication, documentation, and troubleshooting skills.
* Ability to work on-site in Limerick and collaborate across multidisciplinary project teams.