Our client, a global pharmaceutical leader in Dublin, is seeking an experienced and driven Validation Manager to join their Quality team.
This is a key leadership role supporting the validation lifecycle across equipment, facilities, utilities, automated systems, processes, and cleaning procedures — ensuring compliance with cGMP, regulatory expectations, and internal standards. The successful candidate will be a subject matter expert with a strong background in Computer System Validation and digital technologies.
Key Responsibilities
* Act as the site SME for Computer System Validation, Cleaning, Process, and Equipment Validation, Data Integrity, Facility Qualification
* Lead preparation, review, and approval of the Site Validation Master Plan
* Develop validation strategies aligned with the Site Master Plan
* Manage and deliver validation efforts for major strategic projects
* Oversee qualification and validation documentation
* Review and approve third-party validation deliverables
* Support commissioning and Site Acceptance Testing (SAT)
* Lead and manage validation deviations and support change controls
* Chair validation meetings and ensure clear documentation of actions and decisions
* Maintain SOPs and policies related to validation activities
* Perform periodic reviews to maintain validation status
* Support investigations and Root Cause Analysis (RCA)
* Drive a culture of safety and quality in all validation-related activities
About You
* Proven experience in a validation leadership role within a regulated pharmaceutical/biotech environment
* Strong knowledge of current GMPs, regulatory expectations, and validation best practices
* Extensive experience in Computer System Validation and digital systems
* Skilled in project management, cross-functional collaboration, and strategic planning
* Excellent communication, analytical, and problem-solving abilities
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