Job Description
Headcount Solutions is seeking a CSV Engineer to join the team at a multinational client’s biotech facility in Dublin. The CSV Engineer will be responsible for validating and maintaining computerized systems to meet regulatory requirements and industry best practices. 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. * Provide guidance and support to project teams regarding CSV principles, best practices, and regulatory expectations. * 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. * Knowledge of software development life cycle (SDLC) and change control processes. * Understanding of data integrity principles and practices. For further information please contact Mick on (phone number removed) or forward details in confidence to