Senior Validation Specialist

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

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 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 site 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.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

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

Employee Status

Regular

Flexible Work Arrangements

Hybrid