CSV Engineer (Computer System Validation Engineer)
My client based in Dublin 15 is looking for a CSV Engineer (Computer System Validation Engineer) to join their team and someone who is 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.
· Stay updated with industry trends, regulatory changes, and advancements in computer system validation practices.
· 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.
For more information and a confidential chat, feel free to reach out to me on [email protected] or call me on 01-482 5494