Clean Utilities SME Engineer

Sanofi; Munster; On-site; EUR 90,000 - 110,000; Full time

Job summary

Sanofi in Waterford, Ireland seeks a Senior Clean Utilities Specialist/SME to act as the technical authority for PW, WFI, CS and cleanroom HVAC in GMP manufacturing.

The role involves owning system design, guiding regulatory readiness, leading investigations, CAPAs, and driving continuous improvement across the site's clean utilities infrastructure.

Qualifications

• Bachelor’s degree in engineering or equivalent technical qualification.
• 7+ years operating GMP critical utility systems in pharma/biotech.
• Experience leading root cause investigations and CAPA development.
• Experience supporting regulatory audits/inspections as SME.
• Familiarity with CMMS, IQ/OQ/PQ, and change control processes.
• Knowledge of emerging digital/PAT technologies is a plus.

Responsibilities

• Lead design reviews for PW, WFI, CS, and HVAC installations or upgrades.
• Develop URS and technical specs for capital projects.
• Serve as site escalation point for complex utility failures.
• Lead root cause investigations and CAPA actions.
• Support regulatory inspections and audits as SME.
• Drive reliability, maintainability and efficiency improvements.
• Pilot new digital technologies for monitoring and data trending.
• Provide mentorship to technicians and engineers; participate in cross‑functional teams.
• Evaluate equipment vendors and manage relationships with OEMs.

Skills

GMP Compliance

Energy Engineering

Utility Systems Design

Project management

Preventative Maintenance

CAPA development

RCA

CMMS

IQ/OQ/PQ

Change control

Digital/PAT awareness

Education

Bachelor's degree in Engineering (Mechanical/Chemical) or related

Tools

URS/Technical specs

Job description

Clean Utilities SME Engineer

• Location: Waterford, Ireland
• Contract type: Fixed- Term, 23-months

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

About the Job

The Senior Clean Utilities Specialist/SME is the site's technical authority for all critical utility systems supporting GMP manufacturing — including Purified Water (PW), Water for Injection (WFI), Clean Steam (CS), and cleanroom HVAC. This is a hands‑on technical expert role responsible for system design integrity, troubleshooting complex technical issues, ensuring regulatory readiness, and driving continuous improvement and innovation across the site's clean utilities infrastructure.

Main Responsibilities

• System Design & Engineering
  • Lead technical design reviews for new installations, upgrades, and modifications to PW, WFI, CS, and HVAC systems
  • Develop User Requirement Specifications (URS) and technical specifications for capital projects
  • Ensure designs incorporate GMP principles
• Troubleshooting & Root Cause Analysis
  • Serve as the site's escalation point for complex technical failures across all clean utility systems
  • Lead root cause investigations and develop robust CAPAs for unplanned utility disruptions, excursions, or EM/chemical/endotoxin deviations
  • Apply advanced troubleshooting techniques (trend analysis, failure mode analysis) to prevent recurrence
• Regulatory Compliance & Audit Support
  • Act as key SME during regulatory inspections and internal/external audits for critical utility systems
  • Ensure ongoing compliance with Pharmacopoeial standards for water and steam quality
  • Support and review qualification documentation (IQ/OQ/PQ) and periodic requalification activities
• Process Optimization & Continuous Improvement
  • Identify and implement reliability, maintainability, and efficiency improvement opportunities
  • Drive continuous improvement initiatives to reduce downtime, extend asset life, and improve system robustness
  • Partner with Reliability Engineering and Planning & Scheduling teams to optimize maintenance strategies
• Technology Innovation & Digitalization
  • Evaluate and pilot emerging technologies for clean utilities applications
  • Champion digitalization of monitoring, alarming, and data trending for critical systems
• Cross-Functional Technical Leadership
  • Provide technical mentorship and training to maintenance technicians and junior engineers
  • Represent clean utilities in cross-functional project teams (Quality, Validation, Production, EHS)
  • Contribute site expertise to network/global technical forums and best-practice sharing
• Vendor Management & Technology Assessment
  • Evaluate and select equipment vendors and service providers for clean utilities systems
  • Manage technical relationships with OEMs and service contractors; assess new technology solutions during capital planning

About You

Required Experience & Capabilities

• Bachelor’s degree in engineering (Mechanical, Chemical, or related) or equivalent technical qualification
• 7+ years of experience operating and troubleshooting GMP critical utility systems in pharmaceutical, biotech, or comparable high-purity manufacturing (semiconductor, food/beverage)
• 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
• Technical skills: GMP Compliance, Energy Engineering, Utility Systems Design, Project management, Preventative and Corrective Maintenance, RCA and CAPA development

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave