Role: CSV EngineerLocation: DublinContract: 12-month contractDaily rate contract.At Hays Specialist Recruitment we have a great opportunity for a CSV Engineer to join our Biopharmaceutical client in Dublin on an initial 12-month contract.The CSV Engineer (Computer System Validation Engineer) is responsible for validating and maintaining computerised systems to meet regulatory requirements and industry best practices.The role involves Lab Analytical Instruments and Automation Systems.Primary responsibilities:Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.Participate in change control processes, assessing the impact of system changes and ensuring appropriate validation activities are performed.Collaborate with vendors and suppliers to ensure compliance with validation requirements for third-party systems.Support regulatory inspections and audits by providing documentation and participating in direct audit discussions related to computer system validation.Qualification of laboratory analytical instruments (e.g Cell Viability Analysers, Liquid Handlers etc.)Qualification of manufacturing automation systems (e.g DeltaV, MES etc.)Requirements:Bachelor's degree in Computer Science, Engineering, or a related field.Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.Experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.Familiarity with validation methodologies, including risk-based validation approaches.Proficiency in creating and executing validation protocols and documenting validation activities.Excellent analytical and problem-solving skills, with attention to detail.Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.Ability to work independently and manage multiple projects simultaneously.Knowledge of software development life cycle (SDLC) and change control processes.Understanding of data integrity principles and practices.64408-1Desired Skills and Experience1. Bachelor's degree in Computer Science, Engineering, or a related field.Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.Experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.Hays Ireland is a trading division of Hays Specialist Recruitment (Ireland) Limited and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C's, Privacy Policy and Disclaimers which can be found