CSV IT Engineer

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 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.

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. 

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.

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.