Job Description
Our client in Dublin are seeking an experienced IT Compliance & Validation Engineer to join their team and support validation activities for applications, systems and digital solutions. You will apply IT, quality and regulatory compliance expertise to assess system requirements against validation and assurance activities using risk-based CSA principles.
Key Responsibilities
* Ensure compliance with applicable GxP regulations, corporate quality policies, and divisional procedures, including data integrity and electronic records requirements
* Develop and maintains risk-based validation and CSA strategies for medium to large systems
* Define validation and assurance approaches for AI-enabled systems used in regulated activities (e.g., quality, manufacturing, laboratory, supply chain, clinical, or safety)
* Perform and review system impact assessments to determine GxP scope, validation requirements, and CSA testing focus based on patient safety, product quality, and data integrity risk
* Develop, review, and approve validation documentation, including Validation Plans, CSA strategies, risk assessments, test plans, protocols, summary reports, and AI impact assessments, in accordance with SLC and quality system requirements
* Lead the planning, coordination, and execution of validation and assurance activities. Communicate compliance and validation status through clear, accurate project reporting to stakeholders
* Support and review automated testing and assurance activities, ensuring testing effort is focused on critical system functionality consistent with CSA principles
* Identify, escalate, and resolve compliance issues that may introduce regulatory, patient safety, product quality, or data integrity risk
* Establish validation tasks, milestones, and timelines, and is accountable for delivery. Capture and report compliance and CSA metrics, identifying opportunities for process improvement and validation efficiency.
Key Requirements
* Bachelor's Degree with 5 years of experience in a regulated life sciences IT or quality systems environment, or equivalent experience
* Demonstrated experience with GxP computer system validation (CSV) and Computer Software Assurance (CSA) in pharmaceutical, biotech, or medical device environments
* Experience supporting or validating AI-enabled, automated, or data-driven systems used in GxP processes, with understanding of data integrity, audit trails, security, and lifecycle controls
* Strong understanding of global life sciences regulations and guidance (e.g., 21 CFR Part 11, EU GMP Annex 11, FDA CSA guidance)
* Strong written and verbal communication skills, with proven ability to collaborate with IT, Quality, Regulatory, and business stakeholders in regulated environments.
Benefits
* Competitive and attractive employee compensation package
* Pension contributions
* Health insurance
* Paid public holidays
Location: Ireland | remote