Lead Clean Utilities Engineer – GMP Systems & Compliance

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

Job summary

Sanofi Waterford seeks a Senior Clean Utilities Specialist/SME to act as the technical authority for PW, WFI, CS, and HVAC, overseeing design integrity, troubleshooting, regulatory readiness and continuous improvement across the site's clean utilities.

You will lead design reviews, develop URS and specs for capital projects, ensure GMP compliance, support audits, and drive reliability initiatives with cross-functional teams.

Qualifications

• Bachelor's degree in engineering (Mechanical, Chemical, or related).
• 7+ years of experience operating and troubleshooting GMP critical utility systems in pharmaceutical, biotech, or comparable high-purity manufacturing.
• Demonstrated experience leading root cause investigations and CAPA development.
• Experience supporting regulatory audits/inspections as a technical SME.
• Working knowledge of CMMS, qualification protocols (IQ/OQ/PQ), and change control processes.
• Familiarity with emerging digital/PAT technologies is a plus.

Responsibilities

• Lead System Design & Engineering for PW, WFI, CS, and HVAC systems.
• Lead technical design reviews for new installations, upgrades, and modifications.
• Develop URS and technical specifications for capital projects.
• Ensure designs incorporate GMP principles and robust qualification (IQ/OQ/PQ).
• Provide RCA, CAPA, and preventive maintenance input during disturbances and audits.

Skills

GMP Utilities

CAPA

Regulatory audits

CMMS

Change control

Root cause analysis

Education

Bachelor's degree in engineering

Job description

Sanofi Waterford seeks a Senior Clean Utilities Specialist/SME to act as the technical authority for PW, WFI, CS, and HVAC, overseeing design integrity, troubleshooting, regulatory readiness and continuous improvement across the site's clean utilities.

You will lead design reviews, develop URS and specs for capital projects, ensure GMP compliance, support audits, and drive reliability initiatives with cross-functional teams.