Senior Validation Specialist: Lead GMP Validation

MSD; Carlow; On-site; EUR 90,000 - 120,000; Full time

Job summary

MSD in Carlow, Ireland seeks a Senior Validation Specialist to lead and execute filter qualification across processes and equipment, partnering with cross-functional teams to ensure regulatory compliance and manufacturing excellence.

You will drive process and equipment qualification, support tech transfers, and manage documentation in line with cGMP guidelines, while championing change controls, risk assessments, and audit readiness at the Carlow site.

Qualifications

• Bachelor's degree in Science, Chemical/Biochemical Engineering, Biotechnology, Pharmacy, or related discipline.
• Proven typically 4+ years in validation, quality engineering, or technical operations within a cGMP-regulated biopharmaceutical or 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 solver capable of leading complex investigations using Lean/Six Sigma tools.
• Collaboration & communication skills with cross-functional teams and clear technical communication.
• Project leadership with scheduling, budget management, and multi-disciplinary delivery.

Responsibilities

• Lead, execute, and document filter qualification and validation studies and related programs.
• Drive development, qualification, and lifecycle management of new production processes.
• Provide validation support for technology transfers and scale‑ups.
• Spearhead investigations, root‑cause analyses, and troubleshooting for validation deviations.
• Generate, review, and approve critical validation documentation per GMP and regulatory expectations.
• Champion change controls, risk assessments, and timely close-out of CAPAs.
• Support regulatory inspections and internal audits with audit-ready documentation.

Skills

cGMP Regulations

Continuous Improvement

Quality Management

GMP Validation

Quality Management Systems

Sterile Manufacturing

Team Leadership

Technical Documentation

Troubleshooting

Validation Testing

Project Leadership

Education

Bachelor's degree in Science or related

Job description

MSD in Carlow, Ireland seeks a Senior Validation Specialist to lead and execute filter qualification across processes and equipment, partnering with cross-functional teams to ensure regulatory compliance and manufacturing excellence.

You will drive process and equipment qualification, support tech transfers, and manage documentation in line with cGMP guidelines, while championing change controls, risk assessments, and audit readiness at the Carlow site.