Job Title: Validation Specialist
Location: Shannon, Co Clare
Contract Type: 6 month contract
Key Responsibilities:
* Validate Excel-based spreadsheets used in analytical test methods for existing and newly developed gene therapy products.
* Develop and maintain comprehensive qualification/validation documentation to ensure compliance with GMP and regulatory standards.
* Support analytical activities by ensuring spreadsheets meet all operational and compliance requirements.
* Manage change controls and deliver validation-related projects with precision and efficiency.
Requirements:
* 5+ years of GMP validation experience in biologics, cell therapy, or gene therapy.
* Demonstrated expertise in spreadsheet validation, data integrity, and compliance.
* Strong documentation skills and understanding of regulatory requirements for analytical systems.
* Experience in managing change controls and project delivery in a GMP setting.
* Attention to detail and a commitment to excellence in data integrity and quality.
Estimated Salary: €60,000 - €80,000 per annum
Benefits:
* Paid Holidays
* Canteen
* Parking
* VHI Pension
* Bonus
* Laptop