Clean Utilities SME Engineer

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

Waterford

Full time

R

Job title : 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

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

The salary range for this position is :54 800,00 - 73 067

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.

We are an R&D driven, AI-powered biopharma company committed to improving people's lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people's lives.

We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world.

Discover more about us visiting or via our movie We are Sanofi ( a career that makes a difference.

Reinvention is in our DNA. It's what drove our evolution from a small French enterprise to one of the world's leading biopharma companies. Whether it's using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people's lives.