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