Clean Utilities Engineering Lead

EFOR; Cork; On-site; EUR 90,000 - 130,000; Full time

Job summary

EFOR is seeking an Engineering Lead for Clean Utilities with a focus on design and integration for pharmaceutical fill-finish facilities. You will oversee PFDs, P&IDs, layouts, and data sheets, ensuring aseptic processing and sterile suite compliance.

The role requires 8+ years in clean utilities design, strong regulatory knowledge (cGMP, FDA/EMA), and proficiency with AutoCAD, Revit or Plant3D. You will coordinate with process, HVAC, automation, and electrical teams, guiding vendors and

Qualifications

• Minimum 8 years in clean utilities design for pharma or sterile facilities.
• Experience with fill-finish or sterile processes is essential.
• Understanding of cGMP/FDA/EMA and ISPE Baseline Guides.
• Proficiency with CAD/3D design tools.

Responsibilities

• Lead design and integration of clean utility systems for fill-finish operations.
• Prepare and review mechanical/design deliverables (PFDs, P&IDs, layouts).
• Ensure sterile/process suites meet aseptic requirements and cleanroom standards.
• Coordinate with multidisciplinary teams to integrate utilities.
• Support commissioning, validation, and vendor document reviews.

Skills

PFDs & P&IDs

Clean utilities design

Regulatory compliance

Project coordination

Vendor reviews

Education

Bachelor’s in Mechanical/Chemical/Process Eng

Tools

AutoCAD

Revit

Plant3D

Job description

The Clean Utilities Project Engineering Lead (Design Focus, Fill-Finish Experience) 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).