As a CSV Engineer, you will play a pivotal role in validating and maintaining our computerized systems to meet stringent regulatory requirements and adhere to industry best practices. You will be instrumental in ensuring the reliability and compliance of our manufacturing automation systems, laboratory analytical instruments, and enterprise systems.
Key Responsibilities
- 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).
Qualifications
Essential
- 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.
Desirable
- 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).
