CSV Engineer

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