IT Validation Specialist

2 weeks ago

Cork, Ireland Catalyx Full time

Overview Catalyx is seeking an IT Validation Specialist to join our team and work on our customer site in Cork. This role focuses on IT systems validation to ensure regulatory compliance, operational requirements, and industry best practices within a pharmaceutical or highly regulated environment.
Responsibilities Manage the qualification of IT systems, including hardware, software, and infrastructure within a GMP lab setting.
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.
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.
Why Join Catalyx At Catalyx we understand that our people are our greatest asset. We offer a Total Rewards package with personal benefits and professional growth opportunities. Catalyx is an Equal Opportunity Employer and is committed to creating a diverse and inclusive workplace. We do not discriminate on protected characteristics and encourage applications from all qualified candidates. We also support international employees by assisting with Critical Skills Visa applications for eligible candidates.
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Location: Mallow, County Cork, Ireland

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