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:
* 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 at +353 (0) 71 9108062.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Information Technology, Quality Assurance, and Engineering
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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