AI Compliance & Validation Engineer

Catalyx is seeking an AI Compliance & Validation Engineer to join our team and work on our customer site in Kerry.

Who We Are:

Catalyx is a machine vision and automation company that integrates technology and people to help global manufacturers and logistics companies achieve next-generation levels of quality and throughput. For over thirty years, the minds behind Catalyx have been at work maximizing operational processes across highly regulated industries by inventing new technology applications and supporting companies with technical experts. With 9 global offices, over 550 team members, and 3,000 projects under our belt (and counting), we have the capabilities and reach to solve unique process problems at scale – and the vision to keep doing what’s never been done before. For more information visit www.catalyx.ai.

The Role:

Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organisations, to empower them to enhance efficiency, and drive success.  As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations.

We are seeking an experienced engineer to support the implementation, validation, and governance of AI-enabled computer vision inspection systems used in pharmaceutical manufacturing.

This role is less focused on developing AI models from scratch and more focused on ensuring that AI inspection technologies are implemented and operated in line with GMP requirements, EU AI Act expectations, and established validation standards.

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

Responsibilities:

• Support the implementation of AI-enabled computer vision inspection systems within pharmaceutical manufacturing and packaging environments.

• Review supplier AI systems and assess their capabilities against regulatory requirements, including model architecture, training data approach, performance characteristics, and change management processes.

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

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

• Establish monitoring approaches for AI performance including model drift detection, accuracy monitoring, and operational performance tracking.

• Support lifecycle management activities including model version control, retraining procedures, and change management.

• Lead or support Computerised System Validation (CSV) / Computer Software Assurance (CSA) activities for AI-enabled inspection systems.

• Develop validation strategies aligned with Annex 11, 21 CFR Part 11, and GAMP guidance.

• Support validation lifecycle documentation including User Requirements Specifications (URS), Functional Specifications, IQ/OQ/PQ documentation, and validation reports.

• Perform statistical validation of inspection system performance including sensitivity, specificity, ROC curves, and false positive / false negative analysis.

• Conduct structured risk assessments such as FMEA related to AI system deployment and operation.

• Support supplier qualification activities including technical assessments and vendor audits.

• Review CE marking requirements and machinery compliance associated with inspection equipment.

• Develop and maintain AI technical documentation aligned with EU AI Act expectations and GMP regulatory requirements.

• Collaborate closely with QA, Validation, Automation, and Engineering teams to ensure compliant deployment and operation of AI inspection technologies.

Requirements:

• 5+ years’ experience working in a GMP-regulated pharmaceutical or medical device manufacturing environment.

• Experience with Computerised System Validation (CSV) or Computer Software Assurance (CSA).

• Experience working with Annex 11 and 21 CFR Part 11 regulated systems.

• Experience reviewing, validating, or implementing AI / ML inspection or computer vision systems.

• Experience conducting risk assessments using structured methodologies such as FMEA.

• Understanding of CE marking and machinery compliance requirements.

• Understanding of machine learning concepts such as supervised learning, CNNs, and model training versus inference.

• Experience performing statistical analysis of inspection system performance including sensitivity, specificity, and ROC analysis.

• Experience supporting validation lifecycle management including URS, functional specifications, IQ/OQ/PQ documentation, and validation reporting.

• Experience developing regulatory documentation for regulated systems.

• Experience working cross-functionally with Quality, Engineering, Automation, and Manufacturing teams.

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.