AI Compliance & Validation Engineer

CatalyxKerry

On-site Full-time

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Experience Level

Experience

Qualifications

Preferred Qualifications:Bachelor's degree in Engineering, Computer Science, or a related field. Proven experience with AI technologies in regulated environments, particularly in pharmaceuticals. Strong understanding of GMP requirements, EU AI Act, and validation standards. Excellent problem-solving skills and the ability to work collaboratively with cross-functional teams.

About the job

Catalyx is actively looking for a dedicated AI Compliance & Validation Engineer to become part of our dynamic team at a client location in Kerry.

About Us:

Catalyx is a pioneering machine vision and automation company, merging cutting-edge technology with skilled professionals to assist global manufacturing and logistics companies in reaching unprecedented standards of quality and efficiency. With over three decades of experience, our team has been instrumental in optimizing operational processes across highly regulated sectors by innovating new technology applications and offering expert support. With 9 global offices, a workforce of over 550, and 3,000 successful projects to date, we have the expertise and global presence to tackle unique process challenges at scale, all while maintaining our vision to achieve the unprecedented. For more details, visit www.catalyx.ai.

Your Role:

As a trusted partner, Catalyx is committed to providing top-notch lifecycle services to highly regulated and high-risk markets. We collaborate closely with life sciences and other regulated organizations to enhance their efficiency and foster success. In line with this commitment, we continuously enhance our on-site teams to bolster customer operations.

We are in search of an experienced engineer to support the deployment, validation, and governance of AI-powered computer vision inspection systems within pharmaceutical manufacturing settings.

This position emphasizes the implementation and operational compliance of AI inspection technologies in accordance with GMP directives, EU AI Act prerequisites, and established validation standards, rather than developing AI models from the ground up.

The ideal candidate will collaborate closely with Engineering, Automation, Quality Assurance, and Validation teams to ensure that AI-driven inspection technologies are deployed in a compliant, effective, and robust manner.

Key Responsibilities:

Assist in the implementation of AI-enabled computer vision inspection systems in pharmaceutical manufacturing and packaging environments.
Evaluate supplier AI systems and assess their compliance with regulatory requirements, focusing on model architecture, training data methodologies, performance metrics, and change management protocols.
Perform classification analysis under the EU AI Act and contribute to the establishment of governance frameworks for AI-enabled systems.
Develop risk-based control strategies for AI systems, encompassing monitoring frameworks, human oversight mandates, and lifecycle governance protocols.

About Catalyx

About Catalyx:At Catalyx, our mission is to redefine the standards of quality and efficiency in manufacturing and logistics. With our deep-rooted commitment to innovation and excellence, we empower organizations across regulated sectors to optimize their operations and achieve remarkable results. Our extensive experience, combined with a talented team, positions us uniquely to tackle complex challenges and deliver tailored solutions that drive success.

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