CSV Engineer

We are seeking an experienced CSV Engineer who will play a pivotal role in validating and maintaining computerized systems to meet regulatory requirements and adhere to industry best practices.

This is a 12 month hourly rate contract position.

Key Responsibilities:

• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for various computer systems and software applications.
• Participate in change control processes, assessing the impact of system changes and overseeing appropriate validation activities.
• Work collaboratively with Quality Assurance, Operations and IT 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.
• Execute qualification of manufacturing automation systems (e.g., DeltaV, MES).

Education / Experience:

• 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.
• Experience working with MES, and DeltaV/SCADA systems.
• In-depth knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and data integrity principles.
• Familiarity with SAP, TrackWise, or similar ERP/QMS platforms.
• Strong Communication skills