Job Summary
We are seeking a motivated and experienced IT professional to join our team as a Computer System Validation Specialist. This role involves ensuring compliance with regulatory requirements, driving improvements in line with regulatory changes, and providing technical oversight for computerised instrument validation processes.
About the Role
This is a full-time position based on site in Raheen, Limerick. The successful candidate will be responsible for managing, coordinating, developing, and executing computer system validation deliverables for new and existing projects. This includes development and management of project plans, prioritizing validation activities in line with overall project schedules, liaising with vendors to design and deploy computerised instrument solutions, participating in and supporting audit activities, and contributing to team meetings.
Key Responsibilities
- Ensure computerized instrument systems comply with regulatory requirements and company policies.
- Provide technical oversight for computerised instrument validation processes, including validation plans, risk assessments, requirement specifications, testing, data migration, SOPs, change controls, and deviation investigations.
- Manage and coordinate computer system validation deliverables for new and existing projects, including project planning and prioritization.
- Liaise with vendors to design and deploy computerised instrument solutions that integrate with existing onsite IT services and infrastructure.
- Participate in and support audit activities and contribute to team meetings.
Requirements
- Bachelor's Degree (Level 8) in Information Technology, Computer Science, Engineering, or related field.
- Minimum of 3+ years of experience in pharmaceutical or regulated industries.
- Extensive knowledge and experience in development and execution of Computer System Validations.
- Understanding of regulatory requirements associated with CSV, including ER/ES, security, and data integrity.
- Analytical and problem-solving skills.
- Excellent communication skills.
Bonus Points
- Experience in administration of computerised lab equipment
- Experience of quality control laboratory IT systems.