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AI Compliance & Validation Engineer

CatalyxKerry
On-site Full-time

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Experience Level

Experience

Qualifications

Qualifications:Proven experience in the implementation and validation of AI and machine learning systems, particularly in regulated environments. Strong understanding of Good Manufacturing Practices (GMP) and the EU AI Act. Ability to work collaboratively in cross-functional teams. Excellent analytical and problem-solving skills. Strong communication skills, both verbal and written.

About the job

Catalyx is actively looking for a skilled AI Compliance & Validation Engineer to become a vital part of our team at a customer site located in Kerry.


About Us:

Catalyx is a pioneering machine vision and automation firm dedicated to merging cutting-edge technology with human expertise, assisting global manufacturers and logistics providers in reaching unparalleled levels of quality and throughput. With over three decades of experience, our team has been instrumental in optimizing operational processes across highly regulated sectors by developing innovative technology solutions and supplying industry experts. Our expanding presence includes 9 global offices, a workforce of over 550 professionals, and the successful execution of 3,000 projects to date. We pride ourselves on our ability to tackle unique challenges at scale and continuously push the boundaries of what is possible. To learn more, please visit www.catalyx.ai.


Position Overview:

As a trusted partner in delivering exceptional lifecycle services to regulated and high-stakes markets, Catalyx is committed to fostering innovation and excellence. We collaborate with life sciences and other highly regulated organizations to enhance operational efficiency and drive meaningful success. We are looking for an experienced engineer to facilitate the implementation, validation, and governance of AI-enhanced computer vision inspection systems utilized in pharmaceutical manufacturing.

This role primarily centers around ensuring that AI inspection technologies comply with Good Manufacturing Practice (GMP) requirements, adhere to the expectations of the EU AI Act, and meet established validation standards, rather than developing AI models from scratch.

The selected candidate will work in close collaboration with Engineering, Automation, Quality Assurance, and Validation teams to ensure that AI-driven inspection technologies are deployed in a compliant, robust, and operationally efficient manner.


Key Responsibilities:

  • Assist in the deployment of AI-enabled computer vision inspection systems within pharmaceutical manufacturing and packaging settings.

  • Evaluate supplier AI systems, examining their capabilities against regulatory standards, including model architecture, training data methodology, performance characteristics, and change management protocols.

  • Perform EU AI Act classification analysis and contribute to the formulation of governance frameworks for AI-enabled systems.

  • Establish risk-based control strategies for AI systems, including monitoring frameworks, human oversight requirements, and lifecycle governance.

About Catalyx

Catalyx: A leader in machine vision and automation solutions, Catalyx integrates advanced technology with human expertise, empowering manufacturers and logistics companies worldwide to achieve next-level quality and efficiency. With a rich history of innovation and a commitment to excellence, we continue to redefine industry standards in highly regulated sectors.

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