Role: Validation Team Lead
Location: Galway

Overview
This position is responsible for leading the Validation function, ensuring full compliance with regulatory requirements and internal quality standards. The role includes ownership of the Validation Master Plan and associated SOPs, oversight of cleaning and process validation, and provision of strategic and operational support across equipment, analytical instruments, utilities, and other validation activities.

Key Responsibilities

• Lead, mentor, and develop the Validation team to drive high performance and engagement.
• Allocate resources effectively and prioritise validation activities to meet business and compliance goals.
• Own, maintain, and update the Validation Master Plan (VMP), ensuring alignment with current regulatory expectations.
• Develop, review, and approve validation-related SOPs, ensuring timely and compliant updates.
• Ensure validation activities are planned, executed, and documented in accordance with GMP and internal standards.
• Oversee process validation for new and existing products, including protocol design, execution, and reporting.
• Manage cleaning validation programmes to ensure robust control of cross-contamination risks.
• Coordinate validation of manufacturing equipment, analytical instruments, and utilities such as HVAC and water systems.
• Ensure timely completion and approval of validation protocols and reports.
• Support technology transfer activities and new product introductions from a validation standpoint.
• Maintain audit-ready validation documentation and support regulatory inspections as required.
• Address audit findings and implement effective corrective actions related to validation processes.
• Drive continuous improvement initiatives and identify opportunities to enhance validation efficiency.
• Implement industry best practices while ensuring alignment with evolving regulatory requirements.

Qualifications & Experience

• Degree in Engineering, Pharmaceutical Science, or a related discipline.
• Minimum 5 years’ experience in validation within a GMP-regulated environment.
• At least 2 years in a supervisory or leadership capacity.
• Strong background in process, cleaning, equipment, and utilities validation.

Skills & Competencies

• Comprehensive understanding of GMP and regulatory expectations for validation.
• Excellent leadership, communication, and organisational skills.
• Strong analytical and problem-solving capabilities.
• Demonstrated ability to motivate and guide teams to meet validation objectives.
• High attention to detail with a commitment to documentation accuracy and compliance.
• Effective cross-functional collaboration skills to support operational requirements.