IT System Validator

4 days ago

Cork, Cork, Ireland beBeeValidation Full time €60,000 - €80,000
Job Title: IT Validation Specialist

Catalyx is seeking a skilled professional to join their team and work on site in Cork. This role focuses on validating IT systems to ensure regulatory compliance, operational requirements, and industry best practices within a pharmaceutical or highly regulated environment.

Key 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.
Requirements:
  • 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 Work With Us:

We understand that our people are our greatest asset. We offer a comprehensive benefits package and opportunities for professional growth. We are committed to creating a diverse and inclusive workplace and welcome applications from all qualified candidates. We support international employees by assisting with visa applications for eligible candidates.

Location: Cork, Ireland

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