Data Validation Specialist
4 days ago
Life Science Recruitment is seeking a Data Validation Specialist to join our client, a global biotech company based in Ireland. This role will be fully on-site at a state-of-the-art manufacturing facility and will play a critical role in ensuring that computerized instrument systems are compliant with regulatory requirements and company policies.
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 processes, in accordance with site and corporate procedures and GMP guidelines.
- Manage, co-ordinate, develop, and execute computer system validation deliverables for new and existing projects.
- Lead computerised instrument upgrades and improvement projects, promoting solutions to business problems.
The Person
- Bachelor's Degree in Information Technology, Computer Science, Engineering, or related field.
- Minimum 5+ years of experience in a biotech or pharmaceutical setting.
- Extensive knowledge and experience in development and execution of Computer system validations, particularly in laboratory systems.
- Experience in administration of computerised lab equipment.
- Demonstrated troubleshooting ability, with an understanding of lab equipment software.
- Extensive understanding of regulatory requirements associated with CSV, including ER/ES (21CFR Part 11), security, and data integrity.
This role offers a unique opportunity to work in a brand new manufacturing facility and drive improvements in line with regulatory changes.
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