Validation Manager
East Galway, Ireland – Full Time - On Site
The Validation Manager is responsible for overseeing all validation activities in line with regulatory requirements and internal quality standards. This role manages the Validation Master Plan (VMP) and associated procedures, ensuring compliant validation of cleaning, processes, equipment, analytical instruments, utilities, and other critical systems. The position provides both strategic direction and hands-on support to deliver best-in-class validation programs.
Key Responsibilities
* Lead, mentor, and develop the Validation team to drive strong performance and engagement.
* Plan and prioritize validation activities to support business goals and regulatory compliance.
* Own, maintain, and execute the Validation Master Plan (VMP) in line with current regulations and our clients requirements.
* Create, review, and approve validation SOPs, ensuring they are current and effectively implemented.
* Ensure all validation activities are executed, documented, and managed according to GMP and internal quality standards.
* Oversee process validation activities for both new and existing products, including protocol development and execution.
* Manage cleaning validation programs to ensure effective contamination control.
* Coordinate validation efforts for equipment, analytical instruments, and utilities (e.g., HVAC, water systems).
* Drive timely completion and approval of validation protocols and final reports.
* Support technology transfers and new product introductions from a validation standpoint.
* Maintain validation documentation in an inspection-ready state to support internal and external audits.
* Lead resolution of audit findings and implement corrective actions related to validation.
* Identify opportunities to optimize validation processes and promote continuous improvement.
* Apply best practices and remain aligned with evolving regulatory requirements and industry standards.
Qualifications & Experience
* Degree in Engineering, Pharmaceutical Science, or a related discipline.
* Minimum of 5 years' experience in validation within a GMP-regulated environment.
* At least 2 years in a validation leadership or supervisory role.
* Proven expertise in process, cleaning, equipment, and utilities validation.
* Strong knowledge of GMP regulations and validation compliance expectations.
* Effective leadership abilities with a focus on developing team capability.
* Excellent planning, organizational, and prioritization skills.
* Strong analytical mindset with solid problem-solving skills.
* Ability to guide and influence cross-functional stakeholders.
* Commitment to high regulatory standards and audit readiness.
* Comprehensive understanding of validation methodologies and principles.
* Detail-oriented, ensuring accuracy and completeness in documentation.
* Collaborative approach with the ability to work effectively across departments.
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For more information and a confidential chat please contact Gerard Cunniffe on