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Senior It Systems Validator

2 weeks ago


Cork, Cork, Ireland beBeeItValidation Full time €70,000 - €100,000
IT Validation Expert

The role of IT validation expert is critical in ensuring compliance with regulatory standards, operational requirements, and industry best practices.

Key Responsibilities:
  • Manage the qualification of IT systems, including hardware, software, and infrastructure within a regulated environment.
  • Validate software applications used in manufacturing, quality control, and other processes.
  • Collaborate with vendors to ensure system validation documentation is complete and accurate.
  • Oversee 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.
  • Author, review, and approve validation documentation, including plans, reports, and risk assessments.
  • Ensure all validation activities comply with regulatory standards such as GxP, FDA 21 CFR Part 11, and EMA guidelines.
Requirements:
  • Bachelor's degree in Computer Science, Information Technology, or a related field.
  • 3+ years of experience in IT validation, preferably in a regulated environment.
  • Proficiency in GxP regulations, FDA 21 CFR Part 11, and other relevant standards.
  • Experience with validation of ERP, LIMS, MES, and other 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 results to diverse audiences.

We are an equal opportunity employer committed to diversity and inclusion. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, or any other characteristic protected by applicable law.