Excellent opportunity for a CSV Engineer to join a global biologics company in the west of Ireland. Reporting to the Engineering Manager, this role will validate/qualify and maintain computer systems, including process automation systems, information Systems applications/infrastructure, and enterprise systems (e.g. ERP, Document Management Systems). Experience with Computer Systems Validation in a GMP environment is a prerequisite.
Overview of your responsibilities (full job description available on request):
- Prepare and review validation documents (risk assessments, traceability matrices, validation reports).
- Execute validation protocols for affected systems.
- Manage change controls and compliance tasks (e.g., non-conformances).
- Develop and review CSV procedures and policies.
- Analyse testing results and assess against criteria.
- Investigate issues and recommend solutions or improvements.
- Ensure compliance with EU GMP Annex and identify gaps in computerized systems.
- Audit projects for validation policy compliance.
- Coordinate specification reviews for computerized systems.
- Collaborate with internal teams and external vendors on validation tasks.
- Review and approve vendor validation documents.
Knowledge, Skills and Experience Required for the Role:
- Education: Bachelor's degree in Science, Engineering, or Computer Science; 5+ years in Automation, Computer Systems, and IT Infrastructure Qualification/Validation.
- Enterprise Systems: Proficient with ERP systems in GMP production environments.
- GxP Compliance: Experienced in maintaining GxP computerized systems per Annex 11 requirements.
- Regulatory Knowledge: Familiar with EU GMP, Annex 11, and GAMP5 guidelines.
- Validation Expertise: Skilled in creating and executing Computer System Validation (CSV) protocols and summary reports.
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062