Job Description
We are seeking an experienced and proactive Senior Validation Specialist to join our Technical Operations & Validation team in Carlow.
In this critical role, you will lead, execute, and oversee Filter qualification and validation programs across processes, equipment. You will serve as a subject matter expert partnering cross-functionally to ensure regulatory compliance and operational excellence.
Bring energy, knowledge, innovation, and leadership to carry out the following:
•Validation Strategy & Execution: Lead, execute, and document comprehensive filter qualification and validation studies and additional validation programs where required.
•Process & Equipment Qualification: Drive development, qualification, and lifecycle management of new production processes.
•New Product Introduction: Provide robust technical and validation support for technology transfers and commercial manufacturing scale-ups.
•Troubleshooting & Investigations: Spearhead technical investigations, root-cause analyses, and troubleshooting for complex validation deviations and study anomalies.
•Documentation Lifecycle: Generate, review, and approve critical validation documentation, ensuring alignment with current Good Manufacturing Practices and global regulatory expectations.
•Commitment Management: Champion change controls, risk assessments and the timely close-out of corrective and preventive actions.
•Audit & Inspection Readiness: Actively support regulatory agency inspections and internal audits, including authoring storyboards, presenting technical data to inspectors, and maintaining audit-ready documentation.
•Quality Management System: Champion site adherence to corporate quality standards, industry guidelines, and regulatory frameworks.
•Project Oversight & Scheduling: Lead multiple cross-functional validation projects from inception through completion; manage timelines, resource allocation, and budget requirements.
•Continuous Improvement: Drive operational excellence and continuous improvement initiatives.
•Production System methodologies, Lean principles, and problem-solving tools.
•Culture & Collaboration: Actively foster a safe, inclusive, speak-up culture at our Carlow site, promoting shared learning, team capability building, and professional development.
Qualifications, Skills & Experience you will bring
•Bachelor's degree (or higher) in Science, Chemical/Biochemical Engineering, Biotechnology, Pharmacy, or a related discipline.
•Proven experience (typically 4+ years) in validation, quality engineering, or technical operations within a cGMP-regulated biopharmaceutical or pharmaceutical environment.
•Demonstrated hands-on experience in filter validation, sterile/aseptic processing, equipment qualification, or cleaning/process validation.
•Strong working knowledge of EU/FDA cGMP guidelines.
•Analytical Problem Solver: Proven capability in leading complex investigations and utilizing structured Lean/Six Sigma problem-solving tools.
•Collaboration & Communication: Outstanding interpersonal and stakeholder management skills, with the ability to influence cross-functional teams and present technical content clearly.
•Project Leadership: Demonstrated accountability for scheduling, budget management, and multi-disciplinary project delivery.
Our facility in Carlow broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories and temperature-controlled warehousing units.
The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.
Flexible Work Arrangements: Hybrid
Required Skills: cGMP Regulations, Continuous Improvement, Corporate Quality Management, GMP Validation, Quality Management, Quality Management Systems (QMS), Sterile Manufacturing, Team Leadership, Technical Documentation Management, Technical Support, Troubleshooting, Validation Testing
