Clean Utilities Lead

Desired Skills: clean utilities,commissioning,qualification,validation

The role

PE Global is currently recruiting for a Clean Utilities Lead on behalf of a leading pharmaceutical company based in Cork. This is an initial 12 month contract.

Job Purpose

The Clean Utilities Lead is responsible for the technical planning, system design, and cross-discipline coordination of clean utilities—including purified water, WFI, clean steam, process gases, and related systems—specifically supporting pharmaceutical fill-finish facility projects. The role ensures best-in-class clean utility system design, compliance with industry and regulatory standards, and effective support for critical fill-finish operations.

Key Responsibilities

• Lead the design and integration of clean utility systems (purified water, WFI, clean steam, process gases, clean compressed air, etc.) for fill-finish operations, including aseptic preparation, formulation, filling, and finish processes.
• Oversee preparation and review of mechanical/process design deliverables including PFDs, P&IDs, layouts, calculations, specifications, equipment lists, and datasheets tailored to fill-finish production needs.
• Ensure all designs address the specific requirements of sterile product manufacturing, filling suites, cleanrooms, and critical utilities supporting aseptic processing.
• Coordinate with multidisciplinary teams (process, HVAC, automation, electrical, architectural, etc.) to ensure seamless integration of clean utilities into highly regulated fill-finish environments.
• Engage with clients, project stakeholders, and end users to clarify requirements for clean utilities supporting filling, capping, lyophilization, and secondary packaging equipment.
• Maintain project design schedules, track deliverables, and ensure technical quality and on-time completion.
• Conduct and participate in design reviews, HAZOPs, risk assessments, and value engineering workshops focused on aseptic and fill-finish facility operations.
• Provide technical support to procurement, reviewing technical specifications and vendor documents for clean utility equipment critical for fill-finish (e.g., point-of-use WFI delivery, temperature/pressure control, redundancy).
• Support constructability reviews and provide expert guidance during installation and construction of utilities in fill-finish production suites.
• Support commissioning and validation teams with design clarifications related to utilities serving critical filling, sterilization, and cleanroom processes.
• Mentor and develop junior engineers on best practices for design within fill-finish and sterile facility projects.

Qualifications & Experience

• Bachelor’s degree (or higher) in Mechanical, Chemical, Process Engineering, or a related field.
• Minimum 8 years’ professional experience in clean utilities design, with demonstrated experience on fill-finish or sterile pharmaceutical facility projects.
• In-depth understanding of clean utility requirements and integration for fill-finish operations, including support for aseptic manufacturing, capping/closing, lyophilization, and secondary containment.
• Proven experience producing and managing detailed engineering design packages for fill-finish and other high-containment or sterile pharmaceutical environments.
• Expert knowledge of cGMP, FDA/EMA regulations, ISPE Baseline Guides (especially for sterile and aseptic processes), and relevant design standards.
• Proficiency with engineering design software (e.g., AutoCAD, Revit, Plant3D, or equivalent).

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***