Senior Sterile Equipment Validation Engineer

Morgan McKinley; Galway; On-site; EUR 70,000 - 100,000; Full time

Job summary

Morgan McKinley is seeking an Equipment Validation Engineer to drive qualification and validation of equipment, clean utilities, and automated systems in sterile injectable manufacturing. The role ensures assets stay in a validated state and ready for operation.

You will develop IQ/OQ/PQ protocols, lead aseptic processing qualification, and support regulatory inspections with robust validation data. Strong cross-functional collaboration and problem solving are essential.

Qualifications

• Bachelor's or Master's degree in Engineering, Science, or related field.
• 4-5 years in validation within a sterile injectables environment.
• Hands-on knowledge of IQ/OQ/PQ, full lifecycle validation (FAT/SAT to PQ), CSV.
• Clear understanding of Annex 1, ICH Q9/Q10, and FDA Process Validation guidance.
• Strong analytical, project management, and cross-functional leadership skills.

Responsibilities

• Develop, execute, and review IQ/OQ/PQ for sterile equipment and utilities.
• Lead qualification for aseptic filling lines, autoclaves, depyrogenation tunnels, and isolators/RABS.
• Prepare validation documentation and provide data during regulatory inspections.
• Conduct FMEA risk assessments, investigate deviations/CAPAs, and manage change controls.
• Collaborate with Engineering, Quality, and Operations to streamline qualification cycles.

Skills

Validation experience

Project management

Cross-functional leadership

Quality systems

Problem solving

Education

Bachelor's or Master's in Engineering/Science

Tools

IQ/OQ/PQ

Job description

Morgan McKinley is seeking an Equipment Validation Engineer to drive qualification and validation of equipment, clean utilities, and automated systems in sterile injectable manufacturing. The role ensures assets stay in a validated state and ready for operation.

You will develop IQ/OQ/PQ protocols, lead aseptic processing qualification, and support regulatory inspections with robust validation data. Strong cross-functional collaboration and problem solving are essential.