CSV Engineer

We are supporting a global biopharmaceutical organisation with a state-of-the-art greenfield manufacturing facility in Tralee, Co. Kerry, which is targeting operational readiness by the end of 2026. As part of the site build and commissioning phase, we are seeking an experienced CSV Engineer to support validation activities, with a strong focus on QC laboratory systems and equipment.

The successful candidate will be responsible for delivering Computer System Validation (CSV) activities related to QC equipment and associated systems, ensuring compliance with GMP and data integrity requirements during a critical phase of the project.

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• Lead and execute CSV activities for QC laboratory equipment and systems
  
• Develop and review validation documentation including URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, and test scripts
  
• Ensure compliance with regulatory standards including FDA, EU GMP, GAMP5, and data integrity (ALCOA+) principles
  
• Support system integration, data integrity assessments, and audit readiness activities
  
• Collaborate with cross-functional teams including QC, IT, Automation, and Quality
  
• Participate in system walkdowns, troubleshooting, and issue resolution during validation phases
  
• Support deviation investigations, CAPA, and change control processes
  

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• Degree in Engineering, Computer Science, or a related discipline
  
• Proven experience in CSV within pharmaceutical or biotech environments
  
• Strong experience validating QC laboratory xcfaprz systems/equipment (e.g. HPLC, GC, Empower, LIMS, etc.)
  
• Solid understanding of GMP, GAMP5, and data integrity requirements
  
• Experience in project-based environments, ideally within start-up or greenfield sites
  
• Excellent documentation and stakeholder communication skills
  

This is an excellent opportunity to join a high-profile greenfield project with a global organisation, contributing to the delivery of a next-generation manufacturing facility.