Are you interested in taking the next step in your career with a global leader in the life sciences industry? Are you ready to challenge yourself in a fast-paced and highly regulated environment? Are you an experienced IT Compliance & Validation Engineer with a background in GxP? You could be the perfect candidate for this opportunity Don't hesitate, apply todayJob DescriptionOur 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 ResponsibilitiesEnsure compliance with applicable GxP regulations, corporate quality policies, and divisional procedures, including data integrity and electronic records requirementsDevelop and maintains risk-based validation and CSA strategies for medium to large systemsDefine 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 riskDevelop, 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 requirementsLead the planning, coordination, and execution of validation and assurance activities. Communicate compliance and validation status through clear, accurate project reporting to stakeholdersSupport and review automated testing and assurance activities, ensuring testing effort is focused on critical system functionality consistent with CSA principlesIdentify, escalate, and resolve compliance issues that may introduce regulatory, patient safety, product quality, or data integrity riskEstablish 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 RequirementsBachelor's Degree with 5 years of experience in a regulated life sciences IT or quality systems environment, or equivalent experienceDemonstrated experience with GxP computer system validation (CSV) and Computer Software Assurance (CSA) in pharmaceutical, biotech, or medical device environmentsExperience supporting or validating AI-enabled, automated, or data-driven systems used in GxP processes, with understanding of data integrity, audit trails, security, and lifecycle controlsStrong 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.BenefitsCompetitive and attractive employee compensation packagePension contributionsHealth insurancePaid public holidaysLocation:Ireland | remoteDesired Skills and ExperienceEnsure compliance with applicable GxP regulations, corporate quality policies, and divisional procedures, including data integrity and electronic records requirementsDevelop and maintains risk-based validation and CSA strategies for medium to large systemsDefine 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 riskDevelop, 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 requirementsLead the planning, coordination, and execution of validation and assurance activities. Communicate compliance and validation status through clear, accurate project reporting to stakeholdersSupport and review automated testing and assurance activities, ensuring testing effort is focused on critical system functionality consistent with CSA principlesIdentify, escalate, and resolve compliance issues that may introduce regulatory, patient safety, product quality, or data integrity riskEstablish 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.Bachelor's Degree with 5 years of experience in a regulated life sciences IT or quality systems environment, or equivalent experienceDemonstrated experience with GxP computer system validation (CSV) and Computer Software Assurance (CSA) in pharmaceutical, biotech, or medical device environmentsExperience supporting or validating AI-enabled, automated, or data-driven systems used in GxP processes, with understanding of data integrity, audit trails, security, and lifecycle controlsStrong 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.