Senior Clean Utilities Specialist

€45.00 - €60 per hour parking, subsidized canteen and gym

Jenn at Wallace Myers is recruiting a Senior Clean Utilities Specialist to work on contract at Sanofi in Waterford.

Job Title: Senior Clean Utilities Specialist / SME

Job Family: Engineering & Maintenance

Job Category: Utilities & Energy

Reports to: Head of Clean Utilities and Sustainability

Scope: Single Site

Type: Ltd contract

Duration: 23 months

Role Summary

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), CIP/SIP systems, and cleanroom HVAC. This is a hands-on technical expert role (75% technical execution, 25% strategic leadership) responsible for system design integrity, troubleshooting complex technical issues, ensuring regulatory readiness, driving continuous improvement and innovation, implementing industry standards, coaching technical teams, and engaging with professional communities.

Main Accountabilities

• Regulatory Compliance & Audit Support
• Standards Compliance & Implementation
• Process Optimization & Continuous Improvement
• Technology Innovation & Digitalization
• Coaching & Knowledge Leadership
• Professional Community Engagement & Industry Networking
• Cross-Functional Technical Leadership

Required Experience & Qualifications Education

• Bachelor's degree in Engineering (Mechanical, Chemical, or related) or equivalent technical qualification
• Advanced certifications in GMP, validation, or specialized clean utilities training (desirable)

Professional Experience

• 12-15 years of experience operating and troubleshooting GMP critical utility systems in pharmaceutical, biotech, or comparable high-purity manufacturing (semiconductor, food/beverage)
• 5 years in a senior/SME capacity with demonstrated technical authority and leadership
• Demonstrated track record of leading major utility system implementations, upgrades, or technology transitions
• Demonstrated experience leading root cause investigations and CAPA development
• Experience supporting regulatory audits/inspections as a technical SME
• Experience implementing new industry standards or regulatory requirements
• Track record of coaching and mentoring technical staff
• Active participation in professional organizations or industry forums
• Experience presenting at technical conferences or contributing to industry publications (desirable)

Technical Knowledge

• Working knowledge of CMMS, qualification protocols (IQ/OQ/PQ), and change control processes
• Familiarity with emerging digital/PAT technologies and predictive maintenance approaches
• Understanding of Lean/Six Sigma continuous improvement methodologies
• Knowledge of industry standards bodies (ISPE, ASTM, USP, EP) and standards development processes

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