Réalta Technologies is seeking an experienced CSV Engineer with a strong focus on Data Integrity (DI) to join our team and work with one of our pharmaceutical clients based in Cork. This role will not be a traditional, broad Computer System Validation (CSV) position, but instead will centre on risk-based approaches to data integrity, governance, and compliance across GxP-regulated systems.
The successful candidate will bring expertise in assessing data integrity risks, implementing mitigation strategies, and ensuring compliance with regulatory expectations (FDA, EMA, MHRA, Annex 11, 21 CFR Part 11). You will work cross-functionally with IT, Quality, and Operations teams to ensure that systems and processes handling critical data are robust, reliable, and audit-ready.
Key Responsibilities
* Perform data integrity risk assessments on GxP-critical systems and processes.
* Define and implement risk-based validation and compliance strategies aligned with DI principles.
* Support the development of policies, procedures, and technical controls to maintain data accuracy, completeness, consistency, and traceability.
* Provide subject matter expertise in data integrity regulations and guidance (e.g., GxP Data Integrity Guidance, ALCOA+ principles).
* Partner with IT, QA, and system owners to design and implement effective data lifecycle controls.
* Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and relevant industry standards.
* Lead investigations and remediation activities where data integrity gaps are identified.
* Support regulatory inspections and internal audits, acting as a data integrity SME.
* Contribute to continuous improvement of the DI compliance framework.
Key Requirements
* Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.
* Proven experience in CSV within regulated industries, with a strong emphasis on data integrity and risk-based validation.
* In-depth knowledge of regulatory requirements for DI and electronic records/e-signatures.
* Familiarity with GAMP 5, ALCOA+, and risk-based validation approaches.
* Strong understanding of system life cycle management, audit trails, access controls, and data security principles.
* Excellent documentation, problem-solving, and stakeholder management skills.