Catalyx is seeking a CSV/ IT Engineer join our team and work on our customer site in Cork.

WHO WE ARE:

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services RD, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company’s experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai.

SKILLS AND EXPERIENCE:

• Bachelor’s degree in Computer Science, Information Technology, or a related field.
• 3+ years of experience in IT validation, preferably in a pharmaceutical or regulated environment.
• In-depth knowledge of GxP regulations, FDA 21 CFR Part 11, and other relevant standards.
• Experience with validation of ERP, LIMS, MES, and other pharma-specific IT systems.
• Strong understanding of software development lifecycle (SDLC) and validation best practices.
• Familiarity with IT infrastructure, database management, and networking in a validated environment.
• Excellent problem-solving, analytical, and organizational skills.
• Strong written and verbal communication skills, with the ability to present validation results to diverse audiences.

and Performance Qualification (PQ).

• Author, review and approve validation documentation, including validation plans, reports, and risk assessments.
• Ensure all validation activities comply with regulatory standards such as GxP, FDA 21 CFR Part 11, and EM

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 IT Validation Specialist to join our team working within the pharmaceutical sector. This role is critical in ensuring that all IT systems and software comply with regulatory standards, operational requirements, and industry best practices. The ideal candidate will have a strong background in IT Infrastructure, computer system validation (CSV) and regulatory compliance with prior experience in a pharmaceutical or highly regulated environment.

RESPONSIBILITIES:

• Manage the qualification of IT systems, including hardware, software, and infrastructure.
• Validate software applications used in manufacturing, quality control, and other pharmaceutical processes.
• Collaborate with software vendors to ensure system validation documentation is complete and accurate.
• Manage the lifecycle of validated software, including upgrades and decommissioning.
• Perform periodic reviews of validated systems to ensure continued compliance.
• Develop and maintain traceability matrices to ensure alignment with user requirements.
• Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ),

and Performance Qualification (PQ).

• Author, review and approve validation documentation, including validation plans, reports, and risk assessments.
• Ensure all validation activities comply with regulatory standards such as GxP, FDA 21 CFR Part 11, and EMA

guidelines

• Prepare validation summaries, deviation reports, and corrective/preventive action (CAPA) plans.