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.
Role Summary:
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.
Key Responsibilities:
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
Requirements:
Degree in Engineering, Computer Science, or a related discipline
Proven experience in CSV within pharmaceutical or biotech environments
Strong experience validating QC laboratory 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
Additional Information:
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.
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