Senior Validation Specialist - cGMP | Hybrid

Msd Ireland; Carlow; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

MSD Ireland in Carlow seeks an experienced Senior Validation Specialist to lead and oversee filter qualification programs across processes and equipment, partnering across functions to ensure regulatory compliance and operational excellence.

You will drive qualification lifecycle, support technology transfers and scale-ups, lead investigations, and prepare audit-ready documentation in line with cGMP and FDA/EU guidelines, fostering a culture of continuous improvement and collaboration.

Qualifications

• Bachelor’s degree (or higher) in Science, Chemical/Biochemical Engineering, Biotechnology, Pharmacy, or related discipline.
• Proven 4+ years in validation, quality engineering, or technical operations within a cGMP-biopharmaceutical/pharma environment.
• Hands-on experience in filter validation, sterile/aseptic processing, equipment qualification, or cleaning/validation.
• Strong working knowledge of EU/FDA cGMP guidelines.
• Analytical problem solving using Lean/Six Sigma tools.
• Collaborative and strong stakeholder management with cross-functional influence.
• Proven project leadership including scheduling, budgeting, and multi-disciplinary delivery.

Responsibilities

• Lead, execute, and document comprehensive filter qualification and validation studies and related programs.
• Drive qualification and lifecycle management of new production processes.
• Provide validation support for technology transfers and scale-ups.
• Lead investigations and root-cause analyses for validation deviations.
• Generate, review, and approve validation documentation in line with cGMP and regulatory expectations.
• Champion change controls, risk assessments and CAPA close-out.
• Support regulatory inspections and internal audits with audit-ready documentation.
• Ensure adherence to quality standards and regulatory frameworks across site operations.
• Oversee multiple cross-functional validation projects from inception to completion; manage timelines and budgets.
• Drive continuous improvement and Lean principles within Production and Validation.

Skills

cGMP

Continuous Improvement

Quality Management

GMP Validation

Leadership

QMS

Sterile Manufacturing

Documentation

Troubleshooting

Validation Testing

Lean/Six Sigma

Education

Bachelor’s degree in Science/Engineering/Pharmacy

Tools

Lean/Six Sigma

Job description

MSD Ireland in Carlow seeks an experienced Senior Validation Specialist to lead and oversee filter qualification programs across processes and equipment, partnering across functions to ensure regulatory compliance and operational excellence.

You will drive qualification lifecycle, support technology transfers and scale-ups, lead investigations, and prepare audit-ready documentation in line with cGMP and FDA/EU guidelines, fostering a culture of continuous improvement and collaboration.