IT Validation Professional

2 weeks ago

Cork, Cork, Ireland beBeeValidation Full time €80,000 - €100,000

Role Summary:

Catalyx seeks an IT Validation Specialist with expertise in IT infrastructure, computer system validation and regulatory compliance. This role is critical to ensuring that all IT systems and software comply with industry standards and best practices.

  • Manage the qualification of IT systems, including hardware, software, and infrastructure within a controlled environment.

  • Validate software applications used in manufacturing, quality control, and other processes.

  • Collaborate with vendors to ensure 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 action plans.

Requirements:

  • Bachelor's degree in Computer Science, Information Technology, or related field.

  • 3+ years experience in IT validation, preferably in a regulated environment.

  • In-depth knowledge of GxP regulations, FDA 21 CFR Part 11, and relevant standards.

  • Experience with validation of ERP, LIMS, MES, and other IT systems.

  • Strong understanding of software development lifecycle and validation best practices.

  • Familiarity with IT infrastructure, database management, and networking in a controlled environment.

  • Excellent problem-solving, analytical, and organizational skills.

  • Strong written and verbal communication skills, with ability to present validation results to diverse audiences.

What We Offer:

At Catalyx, we value our employees and offer a Total Rewards package, including great personal benefits and professional growth opportunities.

We are an Equal Opportunity Employer, committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported.

We proudly support international employees by offering assistance with visa applications for eligible candidates.

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