IT Validation Specialist

About the role

We are looking for an IT Validation Specialist to join Catalyx’s on‑site team at a customer location in Cork. The role supports pharmaceutical operations by ensuring that all IT hardware, software and infrastructure meet regulatory and quality standards.

Key responsibilities

• Manage qualification of IT systems, including hardware, software and infrastructure in a GMP laboratory environment.
• Validate software applications used in manufacturing, quality control and other pharmaceutical processes.
• Collaborate with vendors to produce complete validation documentation.
• Oversee the lifecycle of validated software, handling upgrades, de‑commissioning and periodic compliance reviews.
• Develop and maintain traceability matrices linking user requirements to validation evidence.
• Create and execute Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols.
• Author, review and approve validation plans, reports, risk assessments and CAPA documentation.
• Ensure all activities comply with GxP, FDA 21 CFR Part 11 and EMA guidelines.

Required profile

• Bachelor’s degree in Computer Science, Information Technology or a related discipline.
• Minimum 3 years of experience in IT validation within a pharmaceutical or other highly regulated environment.
• Strong understanding of GMP and regulatory compliance frameworks.

Required skills

• IT Infrastructure
• Computer System Validation (CSV)
• GMP and GxP knowledge
• FDA 21 CFR Part 11 compliance
• EMA guideline familiarity
• IQ/OQ/PQ protocol development