Senior Clean Utilities Engineer – GMP Water Systems

Sanofi; Waterford; On-site; EUR 55,000 - 73,000; Part time

Job summary

Sanofi in Waterford, Ireland, is seeking a Senior Clean Utilities Specialist/SME to be the technical authority for PW, WFI, CS, and HVAC systems in GMP manufacturing. This hands-on role focuses on design integrity, troubleshooting, regulatory readiness, and continuous improvement across the clean utilities infrastructure.

Applicants should have a Bachelor’s degree in engineering and 7+ years of experience, plus strong knowledge of GMP principles, qualification protocols, and change control.

Qualifications

• Bachelor's degree in engineering (Mechanical, Chemical, or related) and 7+ years of experience.
• Experience operating and troubleshooting GMP critical utility systems.
• Demonstrated experience leading root cause investigations and CAPA development.
• Experience supporting regulatory audits/inspections as a technical SME.

Responsibilities

• Lead technical design reviews for PW, WFI, CS, and HVAC systems.
• Develop URS and technical specs for capital projects.
• Support regulatory inspections and audits as SME for critical utility systems.
• Lead root cause investigations and CAPA development for excursions and deviations.
• Drive continuous improvement to reduce downtime and extend asset life.

Skills

GMP Compliance

Energy Engineering

Utility Systems Design

Project Management

RCA & CAPA

Education

Engineering degree (Mechanical/Chemical)

Tools

CMMS

IQ/OQ/PQ

Change Control

Job description

Sanofi in Waterford, Ireland, is seeking a Senior Clean Utilities Specialist/SME to be the technical authority for PW, WFI, CS, and HVAC systems in GMP manufacturing. This hands-on role focuses on design integrity, troubleshooting, regulatory readiness, and continuous improvement across the clean utilities infrastructure.

Applicants should have a Bachelor’s degree in engineering and 7+ years of experience, plus strong knowledge of GMP principles, qualification protocols, and change control.