Validation Engineer

Validation Engineer - Hanley Calibration (Dublin, Dun Laoghaire)

Hanley Calibration is seeking a Validation Engineer to join our team supporting a long-standing partnership with a global biopharmaceutical leader. This role involves working on critical capital projects and routine activities within a highly regulated environment, ensuring compliance with GMP and quality standards.

Key Responsibilities

• Provide technical expertise in Controlled Temperature Chambers (CTCs) to meet site objectives.
• Prepare, execute, and document validation protocols and reports in accordance with GMP and regulatory requirements.
• Perform thermal mapping executions for CTCs and manage periodic reviews and requalifications in line with the validation master plan.
• Develop and maintain Standard Operating Procedures (SOPs) to meet site and corporate requirements.
• Assist in creating User Requirement Specifications (URS) and Quality Risk Assessments for equipment and automated systems.
• Participate in cross-functional teams and contribute to investigations and continuous improvement initiatives.
• Ensure compliance with site safety requirements and champion safe working practices.

Qualifications & Experience

• Bachelor's degree in Science or Engineering (or equivalent).
• Knowledge of cGMP and regulatory requirements.
• Strong problem-solving skills with excellent written and verbal communication.
• Proficiency in Microsoft Office; experience with Ellab thermal mapping systems and KNEAT software is desirable.
• Previous experience in the pharmaceutical industry is an advantage.

Why Hanley Calibration?

• Work on high-impact projects in collaboration with a world-class biopharmaceutical facility.
• Gain exposure to advanced technologies and industry best practices.
• Competitive salary, benefits, and opportunities for professional development.

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