Senior Validation Lead - Hybrid Biopharma Ops

Merck; Ireland; Hybrid; EUR 75,000 - 95,000; Full time

Job summary

Merck in Carlow is seeking an experienced Senior Validation Specialist to lead, execute, and oversee filter qualification and validation programs across processes and equipment. You will partner cross-functionally to ensure regulatory compliance and operational excellence.

The role supports qualification of production processes, technology transfers, and continuous improvement, with a focus on audit readiness and quality management. A hybrid working model is available at this Carlow site.

Qualifications

• 4+ years' 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.
• Strong working knowledge of EU/FDA cGMP guidelines.

Responsibilities

• Lead, execute, and document comprehensive filter qualification and validation studies.
• Drive development, qualification, and lifecycle management of new production processes.
• Provide robust technical validation support for technology transfers and scale-ups.

Skills

cGMP Regulations

Analytical Problem Solver

Collaboration & Communication

Project Leadership

Education

Bachelor's degree or higher in Science/related field

Tools

Lean Six Sigma

Job description

Merck in Carlow is seeking an experienced Senior Validation Specialist to lead, execute, and oversee filter qualification and validation programs across processes and equipment. You will partner cross-functionally to ensure regulatory compliance and operational excellence.

The role supports qualification of production processes, technology transfers, and continuous improvement, with a focus on audit readiness and quality management. A hybrid working model is available at this Carlow site.