Senior Utilities SME Consultant

About the role

We are seeking an experienced Utilities Subject Matter Expert (SME) to support a major pharmaceutical manufacturing facility fit-out project. This consultant will provide technical leadership during the User Requirements, Conceptual Design, Basic Design, Detailed Design, and Commissioning Planning phases of the project. This is a highly technical role requiring deep expertise in clean utilities, waste systems, and HVAC systems within GMP-regulated biopharmaceutical manufacturing environments.

Duration: Approximately 12-month engagement with potential extension. Start targeted for September 2026.

Required Technical Expertise

• Clean Utilities
  • Water for Injection (WFI)
  • Deionized Water (DI)
  • Purified Water Systems
  • Clean Steam Generation & Distribution
  • Clean Dry Air (CDA)
  • Compressed Gas Systems
• Waste Systems
  • Industrial Waste Systems
  • Aqueous Waste Treatment Systems
  • Wastewater Compliance & Discharge Management
• HVAC
  • Cleanroom HVAC Systems
  • HVAC Controls
  • Room Classification
  • Environmental Control Systems

Responsibilities

• User Requirements Phase
  • Review existing facility and utility infrastructure
  • Develop and update User Requirements Specifications (URS)
  • Ensure compliance with current industry standards and regulations
  • Support facility expansion requirements and utility capacity assessments
• Conceptual & Basic Design
  • Review and evaluate utility design concepts
  • Provide technical leadership on utility architecture and system selection
  • Review utility PFDs and P&IDs
  • Support HVAC strategy development and room classifications
  • Evaluate utility integration with existing facility systems
  • Support wastewater system evaluations and future-state planning
• Detailed Design
  • Review engineering deliverables and design packages
  • Evaluate equipment suitability and utility system performance
  • Drive technical decision-making during design development
  • Coordinate with engineering firms, project teams, and stakeholders
  • Identify and resolve utility-related design issues
• Commissioning Planning
  • Develop commissioning strategy for utility systems
  • Create system-specific commissioning plans
  • Provide technical support during commissioning activities as required

Preferred Background

Ideal candidates will have experience in:

• Pharmaceutical manufacturing facilities
• Biotech manufacturing facilities
• Sterile manufacturing operations
• Facility expansions and fit-out projects
• Greenfield and brownfield projects
• Facilities Engineering
• Utilities Engineering
• Capital Project Delivery
• Commissioning & Qualification
• Engineering consulting firms
• Large pharmaceutical manufacturers