Clean Utilities SME

Our client, a biopharmaceutical company in Waterford, is seeking a Senior Clean Utilities Engineer for GMP manufacturing utilities, including Purified Water (PW), Water for Injection (WFI), Clean Steam, CIP/SIP and cleanroom HVAC. The role combines technical execution and strategic leadership across design, troubleshooting, compliance, improvement and team development.

Responsibilities:

• Lead technical design reviews for new installations, upgrades and modifications to PW, WFI, Clean Steam, CIP/SIP and cleanroom HVAC systems.
• Develop User Requirement Specifications (URS) and technical specifications for capital projects, ensuring appropriate materials, self-draining pipework and prevention of dead legs, biofilm and rouge.
• Act as the technical escalation point for complex utility failures, leading root cause investigations and CAPAs for disruptions, excursions and environmental monitoring, chemical or endotoxin deviations.
• Use trend and failure mode analysis to resolve issues and prevent recurrence.
• Act as the clean utilities SME during regulatory inspections and internal and external audits, including FDA and HPRA inspections.
• Ensure compliance with pharmacopeial water and steam quality requirements and review IQ/OQ/PQ documentation and periodic requalification activities.
• Assess changes to GMP requirements, ISPE and ASTM standards and pharmacopeial guidance, develop remediation plans and lead implementation across clean utilities.
• Maintain standards, specifications and SOPs, communicating regulatory changes and their implications.
• Identify and implement reliability, maintainability, energy efficiency and asset life improvements using Lean and Six Sigma methods, supported by system performance KPIs.
• Work with Reliability Engineering and Planning and Scheduling teams to improve maintenance strategies, reduce downtime and incorporate operational and industry lessons learned.
• Evaluate and pilot process analytical technology (PAT), connected monitoring, predictive maintenance and digital twin applications, improving monitoring, alarming and data trending.
• Coach maintenance technicians, junior engineers and operations staff, and develop training programmes, competency frameworks and technical workshops.
• Support succession planning through mentoring, knowledge transfer and documented guidance.
• Participate in professional bodies, technical committees, standards development and industry forums, sharing knowledge with peers.
• Represent the company at conferences and contribute to publications or presentations where appropriate.
• Represent clean utilities in cross-functional teams with Quality, Validation, Production and EHS, supporting data integrity, regulatory readiness and technical knowledge sharing.
• Support capital project execution and post-implementation improvements, providing input to project prioritisation, maintenance plans, procedures and work instructions.
• Evaluate equipment vendors, service providers and new technologies, undertake technical due diligence and agree technical specifications and performance requirements.
• Manage technical relationships with equipment manufacturers and service contractors, taking accountability for utility design decisions, compliance and safety corrective actions, standards adoption and training development.
• Provide occasional off-hours support and participate in an on-call rotation for critical utility issues and planned shutdowns, with occasional travel for conferences, professional forums and peer site visits.

Qualifications & Experience:

• Bachelor’s degree in Mechanical, Chemical or a related engineering discipline, or an equivalent technical qualification.
• Advanced certifications in GMP, validation or specialist clean utilities training would be advantageous.
• 12 to 15+ years’ experience operating and troubleshooting GMP critical utility systems in pharmaceutical, biotechnology or comparable high-purity manufacturing environments, including semiconductor or food and beverage manufacturing.
• At least five years in a senior specialist or SME role, with technical leadership experience.
• Experience leading utility installations, upgrades, technology transitions, investigations and CAPAs.
• Experience supporting regulatory inspections as a technical SME and implementing new industry standards or regulatory requirements.
• Detailed knowledge of purified water generation and distribution, including reverse osmosis, electrodeionisation, UV treatment and ion exchange.
• Detailed knowledge of distillation and membrane-based WFI generation, storage, distribution and sanitisation, and Clean Steam generation, distribution, condensate quality and SIP/autoclave supply.
• Knowledge of CIP/SIP cycle design, chemical compatibility and cleaning validation support, together with cleanroom airflow, pressure cascades and HEPA filtration integrity.
• Expert knowledge of GMP compliance, energy engineering, utility system design, preventive and corrective maintenance, standards implementation, troubleshooting and root cause analysis.
• Advanced capability in HVAC management, CAPA development, validation support, vendor and contract management, continuous improvement and change management.
• Working knowledge of CMMS, IQ/OQ/PQ qualification protocols and change control, with familiarity with digital/PAT technologies and predictive maintenance.
• Understanding of Lean/Six Sigma methods and relevant ISPE, ASTM, USP and EP standards and standards development processes.
• Experience coaching and mentoring technical staff, developing team capability and working across engineering, quality and operational functions.
• Strong problem-solving and safety compliance skills, with experience in stakeholder management, project management and technical change leadership.
• Active participation in professional organisations or industry forums; technical conference presentations or industry publications would be advantageous.
• Ability to work on site in manufacturing areas and utility rooms in accordance with GMP, safety and cleanroom protocols, with flexibility for global collaboration and industry engagement.