Clean Utilities SME

Tandem Project Management Ltd.; Waterford; On-site; EUR 120,000 - 150,000; Full time

Job summary

Tandem Project Management Ltd. in Waterford seeks a Senior Clean Utilities Engineer to lead GMP utilities including purified water, WFI, clean steam, CIP/SIP and cleanroom HVAC.

The role blends hands-on design and troubleshooting with strategic leadership across projects, compliance, continuous improvement and team development. You will drive URS preparation, technical specs, CAPAs and regulatory readiness, mentor technicians and engineers, and collaborate with Quality, Validation, Production

Qualifications

• Bachelor's degree in Mechanical, Chemical or a related engineering discipline.
• Advanced GMP/validation certifications would be advantageous.
• 12 to 15+ years’ experience operating GMP utility systems in high-purity environments.
• Senior specialist or SME role with technical leadership experience.
• Experience leading utility installations, upgrades and CAPAs.
• Experience supporting regulatory inspections as a technical SME.
• Knowledge of purified water, WFI, Clean Steam and related processes.
• Lean Six Sigma and continuous improvement experience.

Responsibilities

• Lead design reviews for PW, WFI, Clean Steam, CIP/SIP and cleanroom HVAC upgrades.
• Develop URS and technical specifications for capital projects.
• Own root cause investigations, CAPAs and regulatory readiness.
• Mentor maintenance technicians and junior engineers; develop training programs.

Job description

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.