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CSV ENGINEER
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CSV ENGINEER

Réalta Technologies (RT)
Cork, County Cork

Apply Now

Job details

Full-time

Qualifications

Quality management
Manufacturing
Communication skills

Full job description

FULL TIME

Cork, Ireland

Réalta Technologies are seeking a CSV Engineer with 5+ years experience to support validation activities across manufacturing and automation systems within a GMP-regulated environment.

The successful candidate will play a key role in ensuring computerised systems remain compliant with regulatory and site requirements.

Job Responsibilities

Support CSV lifecycle activities for manufacturing, automation, and laboratory systems.
Develop and execute validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, and Traceability Matrices.
Review system changes and support change control activities in line with site procedures.
Work closely with Automation, IT, Engineering, and Quality teams to ensure compliant system delivery.
Support periodic reviews, audit readiness activities, and regulatory inspections.
Assist with deviation investigations, CAPAs, and root cause analysis activities related to validated systems.
Ensure validation activities are completed in accordance with GMP, GAMP 5, 21 CFR Part 11, and Data Integrity requirements.
Support system implementations, upgrades, and remediation projects across the site.

Job Requirements

5+ years’ experience in Computer Systems Validation within Pharmaceutical or regulated manufacturing environments.
Strong knowledge of CSV lifecycle activities and validation documentation development/execution.
Experience validating automation systems, manufacturing systems, or infrastructure platforms.
Good understanding of GMP, GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity principles.
Experience supporting audits, inspections, deviations, and CAPA activities.
Familiarity with change management and quality management systems within regulated environments.
Strong documentation, communication, and stakeholder management skills.
Ability to work across multidisciplinary project and operational teams in a fast-paced GMP environment.

Apply Now

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computer system validation engineer jobs

CSV ENGINEER

CSV Engineer

Quality Engineering Manager

Senior MES Recipe Author

MES Engineer - Syncade

Principal Engineer – Galway, Ireland (Hybrid )

Senior CSV Engineer

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