Clean Utilities SME Engineer

Purpose 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.

Responsibilities 1. System Design & Engineering * Lead technical design reviews for new installations, upgrades, and modifications to PW, WFI, CS, CIP/SIP, and HVAC systems

* Develop User Requirement Specifications (URS) and technical specifications for capital projects

* Ensure designs incorporate GMP principles: no dead legs, self-draining piping, biofilm/rouge prevention, appropriate materials of construction

2. 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

3. Regulatory Compliance & Audit Support * Act as key SME during regulatory inspections and internal/external audits (FDA, HPRA) for critical utility systems

* Ensure ongoing compliance with Pharmacopeial standards for water and steam quality

* Support and review qualification documentation (IQ/OQ/PQ) and periodic requalification activities

4. Standards Compliance & Implementation * Lead implementation of new industry standards (ISPE, ASTM, pharmacopeial updates) across clean utilities systems

* Ensure rigorous adherence to evolving GMP standards, guidelines, and regulatory requirements

* Develop and maintain site standards and technical specifications based on industry best practices

* Conduct gap assessments against new regulatory requirements and drive remediation plans

* Establish and maintain standard operating procedures (SOPs) aligned with latest standards and guidelines

* Champion adoption of emerging standards and drive organizational readiness for regulatory changes

* Maintain current knowledge of industry standards evolution and communicate implications to leadership

5. Process Optimization & Continuous Improvement * Identify and implement reliability, maintainability, and efficiency improvement opportunities

* Drive systematic continuous improvement programs (Lean, Six Sigma methodologies) across utility systems

* Establish key performance indicators (KPIs) and metrics for utility system performance, reliability, and efficiency

* Lead cross-functional improvement initiatives to reduce downtime, extend asset life, and improve system robustness

* Partner with Reliability Engineering and Planning & Scheduling teams to optimize maintenance strategies

* Implement lessons learned from industry networks and internal operations

6. Technology Innovation & Digitalization * Evaluate and pilot emerging technologies (PAT, IoT-based monitoring, predictive maintenance, digital twins) for clean utilities applications

* Champion digitalization of monitoring, alarming, and data trending for critical systems

* Assess new technology solutions during capital planning and vendor evaluation

7. Coaching & Knowledge Leadership * Provide formal coaching and mentoring to maintenance technicians, junior engineers, and operations staff

* Develop training programs and technical competency frameworks for the utilities team

* Lead technical workshops, knowledge transfer sessions, and capability-building initiatives

* Build technical depth and expertise across the utilities team to ensure succession planning

* Establish mentoring relationships and support career development of technical staff

* Document and share technical knowledge through procedures, guidelines, and best practice documentation

8. Professional Community Engagement & Industry Networking * Maintain active membership in professional organizations (ISPE, ASHRAE, ASTM, etc.)

* Participate in industry working groups, technical committees, and standards development initiatives

* Represent the site/company at technical conferences, symposia, and industry forums

* Network with peer SMEs across the pharmaceutical industry to share best practices and lessons learned

* Contribute to industry publications, technical papers, or conference presentations (where appropriate)

* Leverage industry connections to stay current with emerging technologies and regulatory trends

* Serve as site ambassador for clean utilities excellence and innovation

9. Cross-Functional Technical Leadership * Represent clean utilities in cross-functional project teams (Quality, Validation, Production, EHS)

* Contribute site expertise to network/global technical forums and best-practice sharing

* Collaborate with Quality and Compliance on data integrity and regulatory readiness

* Support capital project execution and post-implementation optimization

10. 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 and conduct technical due diligence during capital planning

* Negotiate technical specifications and performance requirements with vendors

Requirements * Bachelor's degree in Engineering (Mechanical, Chemical, or related) or equivalent technical qualification

* Advanced certifications in GMP, validation, or specialized clean utilities training (desirable)

* 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)

* 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

* Site-based role with regular presence in manufacturing areas and utility rooms

* Requires adherence to GMP, safety, and cleanroom protocols

* May require occasional off-hours support for critical system issues or planned shutdowns

* Participation in on-call rotation for critical utility systems

* Travel to industry conferences, professional forums, or peer site visits (occasional)

* Flexible working arrangements to support global collaboration and industry engagement