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Validation engineer

Tralee
Tandem Project Management Limited
Validation engineer
Posted: 18 June
Offer description

Summary: Our pharmaceutical client based in County Kerry is seeking a Validation Specialist with strong experience in calibration and temperature mapping. This role is essential to ensuring compliance with GMP standards and supporting manufacturing operations through accurate environmental qualification and equipment validation. Responsibilities: Plan and execute temperature mapping studies for storage areas, refrigerators, freezers, and cleanrooms in accordance with GMP guidelines. Perform calibration of temperature, pressure, and humidity monitoring devices using certified standards. Prepare and review validation protocols (IQ/OQ/PQ), reports, and risk assessments in line with corporate and regulatory requirements. Coordinate with cross-functional teams including Quality, Engineering, and Facilities for validation scheduling and execution. Ensure data integrity and accuracy in all calibration and mapping documentation. Troubleshoot equipment or validation issues and recommend corrective actions. Maintain equipment and validation documentation in compliance with regulatory and site requirements. Support audits and inspections by providing technical validation data and documentation as required. Qualifications & Experience: Degree in Engineering, Science, Pharmaceutical Technology, or related discipline. Minimum 2-3 years of relevant experience in a GMP-regulated pharmaceutical or biotechnology environment. Demonstrable experience with temperature mapping, data logger setup, and calibration equipment. Working knowledge of validation lifecycle, GMP, GDP, and regulatory standards (e.g., FDA, EMA). Excellent documentation and report-writing skills. Previous equipment knowledge for example pack lines, lyos, autoclaves, Isolator Technology and fill lines would be an advantage.

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