Senior Validation Specialist

About the role

MSD is looking for an experienced and proactive Senior Validation Specialist to join its Technical Operations & Validation team at the Carlow site. The role leads, executes and oversees filter qualification and validation programmes across processes and equipment, acting as a subject matter expert who partners cross-functionally to ensure regulatory compliance and operational excellence.

Key responsibilities

• Lead, execute and document filter qualification and validation studies and other validation programmes where required
• Drive development, qualification and lifecycle management of new production processes
• Provide technical and validation support for technology transfers and commercial scale-ups
• Lead investigations, root-cause analyses and troubleshooting of validation deviations and study anomalies
• Generate, review and approve validation documentation aligned with cGMP and global regulatory expectations
• Support change controls, risk assessments and the timely closure of corrective and preventive actions
• Support regulatory inspections and internal audits, including authoring storyboards and presenting technical data to inspectors
• Champion site adherence to corporate quality standards and industry guidelines
• Lead multiple cross-functional validation projects, managing timelines, resources and budgets
• Promote continuous improvement, Lean principles and a safe, inclusive culture at the site

Required profile

• Bachelor's degree (or higher) in Science, Chemical/Biochemical Engineering, Biotechnology, Pharmacy or a related discipline
• Typically 4+ years of experience in validation, quality engineering or technical operations in a cGMP-regulated biopharmaceutical or pharmaceutical environment
• Hands-on experience in filter validation, sterile/aseptic processing, equipment qualification or cleaning/process validation
• Proven ability to lead complex investigations using Lean/Six Sigma tools
• Strong stakeholder management and communication skills, and accountability for scheduling, budget and multi-disciplinary project delivery

Required skills

• EU/FDA cGMP guidelines
• GMP validation and quality management systems
• Sterile manufacturing and continuous improvement
• Technical documentation management and troubleshooting

The Carlow site, which broke ground in 2008, is a filling site for vaccines, biologics and small molecule drugs. The company offers a hybrid working model for office-based colleagues and flexible arrangements where possible.