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 Validation Engineer with a background in GxP?
You could be the perfect candidate for this opportunity!
Don't hesitate, apply today!
Job Description
Our client in Ireland are seeking experienced IT Compliance & Validation Engineers (CSV) 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 maintain 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)
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
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
Key Requirements
Bachelor's Degree with experience in a regulated life sciences IT or quality systems environment
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: Cork/Dublin, Ireland | remote
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