Job Description
Catalyx is seeking a CSV IT Engineer to work on our customer site based 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 R&D, production, packaging, and delivery processesgloballywith 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, Catalyxs partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. Responsibilities: Develop and execute test scripts to validate computer systems and software applications Develop and maintain validation documentation including validation plans, test scripts, and traceability matrices Perform risk assessments and impact analyses to determine validation requirements Collaborate with cross-functional teams to ensure that computer systems are validated in accordance with company policies and regulatory requirements Participate in internal and external audits and inspections related to computer system validation Provide guidance and support to end-users on computer system validation requirements and best practices Requirements Bachelor's degree in Computer Science, Information Systems, or a related field 3+ years of experience in IT CSV engineering or a related field Strong understanding of regulatory requirements related to computer system validation, including FDA 21 CFR Part 11 and EU Annex 11 Experience with computer system validation in a GMP environment Excellent analytical and problem-solving skills Strong communication and collaboration skills 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.