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 start 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.

• 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.