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.
