CSV Engineer - IT Labs
Reference: | POR / 112848 |
Location: |
Limerick
|
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Permanent | Salary: |
Not Disclosed |
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.
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’Reillyon 087 7094141 or send CV in confidence to [email protected]