About the job
Catalyx is actively searching for a skilled Computer Systems Validation (CSV) Engineer to join our dynamic team at our customer site in Kerry.
About Us:
Catalyx is a pioneering machine vision and automation firm that combines cutting-edge technology with human expertise to empower global manufacturers and logistics companies in achieving unparalleled levels of quality and efficiency. With over thirty years of experience, our team has been dedicated to optimizing operational processes across highly regulated sectors by developing innovative technology applications and providing specialized technical support. With 9 international offices, a workforce of over 550 professionals, and an impressive portfolio of 3,000 projects, we have the resources and vision to tackle unique challenges at scale, continuously pushing the boundaries of what's possible. For further details, please visit www.catalyx.ai.
Your Role:
As a CSV Engineer at Catalyx, you will play a crucial role in delivering exceptional lifecycle services to our partners in regulated and high-risk markets. Our commitment to innovation and excellence drives us to collaborate with life science and other highly regulated organizations, helping them improve efficiency and achieve success. To support our mission, we are consistently enhancing our on-site teams to contribute to the advancement of customer operations.
The CSV Engineer will manage the planning, execution, and documentation of validation activities related to computer systems and software within regulated environments (e.g., pharmaceutical, biotech, medical device, manufacturing). This position ensures adherence to regulatory requirements (FDA 21 CFR Part 11, GxP, EU Annex 11, etc.) and industry standards.
Key Responsibilities:
1. Validation Planning & Execution:
Develop, review, and approve validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Acceptance Test Protocols.
Conduct risk assessments to identify the necessary level of validation.
Create and execute validation test scripts to confirm system functionality, data integrity, and regulatory compliance.
Ensure that validation deliverables align with internal SOPs, industry standards, and regulatory requirements.
2. Documentation & Reporting:
Produce and maintain thorough validation documentation, including Validation Plans and Validation Summary Reports, along with test results.
Keep traceability matrices up-to-date to ensure that all requirements are validated.
3. Compliance & Regulatory Adherence:

