JD – CSV Engineer - GxP Business Systems
We are seeking an experienced Computer System Validation Engineer to support a pharmaceutical manufacturing client in a GMP environment with a programme of validation activity across GxP business systems, application changes, system upgrades and associated data interfaces.
The successful candidate will work closely with IT, Quality Assurance, Supply Chain, Materials SMEs and business process owners to support validation planning, documentation, testing and change control activities through to project close-out.
About the Role:
The CSV Engineer will support the validation of changes across connected business applications and data flows, including system updates, application changes, interface changes and middleware-related processes.
The role requires strong CSV lifecycle knowledge, excellent technical writing skills and the ability to work with business and technical SMEs to ensure validation deliverables are accurate, compliant and aligned to intended system use.
Location: Ulster Region, Ireland.
Term of Contract - 6 months.
Key Responsibilities:
- Support CSV activities for GxP business systems, application changes, system upgrades, interfaces and middleware-related processes.
- Prepare and revise core validation documentation, including URS, Project Validation Plans, risk assessments, test protocols, traceability matrices and system certification/close-out documentation.
- Support change control activities, including impact assessments, validation planning, test execution, deviation management and remediation actions.
- Work with IT, QA, Supply Chain, Materials SMEs and business users to understand system functionality, process changes and validation requirements.
- Support testing activities, including protocol development, execution support, evidence review and issue resolution.
- Ensure validation deliverables are aligned with internal procedures, GAMP 5 principles, data integrity expectations and applicable regulatory requirements.
- Participate in project and validation review meetings, providing CSV input throughout the project lifecycle.
- Support audit and inspection readiness by ensuring validation documentation is complete, traceable and inspection-ready.
Preferred Experience:
- 3–5 years’ experience in Computer System Validation within a pharmaceutical, biotechnology, medical device or regulated GMP environment.
- Experience validating GxP IT systems, business applications, system upgrades, interfaces or middleware.
- Strong understanding of CSV lifecycle documentation, including URS, Project Validation Plans, risk assessments, test protocols, traceability documentation and validation summary reports.
- Experience supporting change control and validation impact assessments.
- Knowledge of GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11 and data integrity principles.
- Experience with ERP, supply chain, logistics, materials management, invoicing, shipping documentation, middleware or interface-related systems would be beneficial.
- Strong technical writing skills and the ability to translate business and system processes into clear validation documentation.
- Excellent communication skills with the ability to work across IT, QA and business SME groups.
Requirements:
- Bachelor’s degree in Computer Science, Engineering, Information Technology, Life Sciences or a related discipline.
- Must be eligible to work in Ireland.
- Must be willing to work on a hybrid basis and attend site as required (4days Onsite - 1 day remote)
Note: All applicants must be residing in Ireland with valid work visa.
Benefits:
- On-site parking
- Work from home
Ability to commute/relocate:
- County Cavan: reliably commute or plan to relocate before starting work (preferred)
Education:
Experience:
- CSV: 3 years (required)
- GxP business systems & application changes: 3 years (preferred)
- Systems upgrade, interfaces and middleware-related processes: 3 years (preferred)
- CS validation documentation: 3 years (preferred)
- GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11, Data Integrity: 3 years (preferred)
- ERP, supply chain, logistics, materials management: 2 years (preferred)
- invoicing, shipping documentation: 2 years (preferred)
Work authorisation:
Work Location: In person
