Computer Systems Validation (CSV) Engineer

Catalyx is seeking a CSV Engineer to work in our facility based in Little Island, Cork.

Who We Are:

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

Job Summary

This role ensures compliance with regulatory requirements (FDA 21 CFR Part 11, GxP, EU Annex 11, etc.) and industry standards.

Responsibilities:

1. Validation Planning & Execution:

• Develop, review, and approve validation protocols, including IQ (Installation Qualification), OQ (Operational Qualification) and Acceptance Test Protocols
• Perform risk assessments to determine the appropriate level of validation required.
• Create and execute validation test scripts to verify system functionality, data integrity, and compliance with regulations.
• Ensure that validation deliverables meet internal SOPs, industry standards, and regulatory requirements.

1. Documentation & Reporting:

• Create and maintain comprehensive validation documentation, including Validation Plans, Validation Summary Reports), and test results.
• Maintain traceability matrices to ensure that all requirements are validated.

1. Compliance & Regulatory Adherence:

• Ensure that all computer systems and software used in regulated activities meet regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
• Stay up to date with regulatory changes and industry best practices.
• Ensure proper electronic records and signatures are in place where applicable.

1. Cross-functional Collaboration:

• Work closely with software development, QA and project management teams to ensure that systems are validated in a timely manner.
• Provide guidance and training to team members on CSV-related topics and best practices.
• Act as the CSV Subject Matter Expert (SME) during internal and external audits, including regulatory inspections.

1. System Management & Support:

• Support the lifecycle management of validated systems, including periodic reviews, revalidation, and system upgrades.
• Troubleshoot and resolve validation issues, ensuring that corrective and preventive actions (CAPAs) are implemented where necessary.
• Oversee change control processes for validated systems to ensure ongoing compliance.

1. Risk Management:

• Conduct risk assessments for system validation projects.
• Implement mitigation strategies to reduce potential validation failures.
• Ensure ongoing monitoring and periodic review of systems for continued compliance.

Qualifications:

Education:

• Bachelor’s degree in computer science, Information Technology, Engineering, or a related technical discipline. Advanced degrees or certifications in validation, quality, or regulatory affairs are a plus.

Experience:

• Minimum of 3-5 years of experience in computer systems validation within regulated industries (pharmaceutical, biotech, medical devices, etc.).
• Experience with FDA 21 CFR Part 11, GAMP 5, and other regulatory guidelines.

Skills:

• Strong knowledge of validation principles, risk management, and GxP environments.
• Proficient in creating and maintaining validation documentation.
• Strong analytical and problem-solving skills.
• Ability to manage multiple validation projects concurrently.
• Excellent communication and interpersonal skills.
• Knowledge of software development life cycle (SDLC) is a plus.

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.