A CSV Engineer – IT Labs is required to join a global biotech company based in Limerick. This role will be fully on site in a brand new state-of-the-art manufacturing facility and will play a critical role in ensuring that computerized instrument systems are in full compliance with regulatory requirements, company policies and procedures and will drive improvements in line with regulatory changes.
The Role Develop in-depth knowledge of IT functionality of relevant lab equipment to aid in installation, upgrade and maintenance activities.Provide technical oversight for computerised instrument validation (CSV) processes, in accordance with site and corporate procedures and GMP guidelines. The activities include, but are not limited to; the oversight for Validation Plans and Strategies, Risk Assessments, Requirement Specifications, Testing, Data Migration, SOPs, Change controls and Deviation Investigations.Manage, co-ordinate, develop and execute computer system validation deliverables for new and existing projects. This includes development and management of project plans, prioritizing validation activities in line with the overall project schedules.Lead computerised instrument upgrades and improvement projects, promoting and providing solutions to business problems. The Person Bachelor's Degree (Level 8) in Information Technology, Computer Science, Engineering or related field.Minimum of 5+ years of experience in a biotech or pharmaceutical setting.Extensive knowledge and experience in development and execution of Computer system validations, in particular the laboratory systems area.Experience in administration of computerised lab equipment.Demonstrated troubleshooting ability, understanding of lab equipment software.Extensive understanding of regulatory requirements associated with CSV, including ER/ES (21CFR Part 11), security and data integrity.
For further details please contact: Paula O'Reilly on 087 7094141 or send CV in confidence to ******.
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