CSV Engineer
- Dublin
- Contract
- Full-time
- Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for various computer systems and software applications.
- Work collaboratively with IT, Quality Assurance, and Operations teams to ensure adherence to regulatory guidelines and internal policies.
- Conduct risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
- Create and maintain comprehensive validation documentation, including validation plans, test scripts, traceability matrices, and validation summary reports.
- Perform periodic reviews to ensure ongoing compliance.
- Participate in change control processes, assessing the impact of system changes and overseeing appropriate validation activities.
- Provide expert guidance and support to project teams on CSV principles, best practices, and regulatory expectations.
- Stay up-to-date with industry trends, regulatory changes, and advancements in computer system validation.
- Collaborate with vendors and suppliers to ensure third-party systems meet validation requirements.
- Support regulatory inspections and audits, providing necessary documentation and participating in direct discussions.
- Perform qualification of laboratory analytical instruments (e.g., Cell Viability Analyzers, Liquid Handlers).
- Execute qualification of manufacturing automation systems (e.g., DeltaV, MES).
- Degree in Computer Science, Engineering, Life Sciences, or equivalent.
- 3+ years' CSV experience in a GMP-regulated pharmaceutical or biotech environment in Ireland or EU.
- Proven ability to produce CSV deliverables and manage validation activities autonomously.
- Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and data integrity principles.
- Experience working with MES, and DeltaV/SCADA systems.
- Familiarity with SAP, TrackWise, or similar ERP/QMS platforms.
- Experience with instrument integration via OPC/communication protocols.
- Previous exposure to regulatory inspections (e.g. HPRA, FDA, EMA).