Utilities SME
GBM_4376741853
Posted: 09/03/2026
- Philadelphia, Pennsylvania, United States
- Contract
Project Overview
A global biopharmaceutical manufacturer is delivering a large-scale GMP CAPEX programme ($1.5B) and is seeking an experienced Utilities SME Consultant to support design review, CQV readiness, and transition to operations across critical clean and black utilities.
The role provides specialist utilities expertise to ensure design decisions enable efficient commissioning, qualification, and long-term operational reliability. Utilities are a critical path workstream within the programme, requiring additional senior SME support due to overlapping projects and constrained internal bandwidth.
Why This Role Is Needed
The utilities workstream is operating with a lean internal team while supporting multiple concurrent CAPEX initiatives. External SME support is required to:
- Strengthen utilities design review
- Identify and mitigate downstream CQV and operational risk early
- Prevent sub-optimal or non-operable utility design decisions
- Enable a faster, smoother transition into operations
Key Responsibilities
- Act as a Utilities SME during design, execution, and readiness phases
- Support a complex GMP utilities scope including:
- WFI, PW, Clean Steam
- CIP/SIP utilities interfaces
- Compressed gases (CDA, N₂, CO₂)
- Chilled water, heating water, process waste
- HVAC interfaces (GMP and non-GMP)
- Perform detailed design and documentation reviews with a strong CQV and operability lens
- Work with System Owners and Stream Leads to:
- Identify design gaps, constructability issues, and CQV risks
- Influence design decisions to minimise downstream qualification impact
- Collaborate closely with:
- Utilities & Process Engineering
- CQV teams
- Capital Projects, QA, and Engineering stakeholders
- Provide pragmatic SME input to:
- Reduce unnecessary testing and rework
- Improve CQV efficiency and execution strategy
- Accelerate readiness for start-up and operations
- Support closure of utilities-related design exceptions prior to commissioning
Stakeholder Interaction
The consultant will be embedded within the project team and interface with:
- Utilities Operations and Engineering stakeholders
- Engineering / Design partners (e.g. IPS or equivalent)
- CQV teams
- Capital Projects, QA, and Site Engineering leadership
Required Experience
- Senior-level Utilities SME background in GMP manufacturing
- Strong experience with:
- Clean and Black Utilities systems
- GMP utilities design, operation, and qualification
- Proven ability to:
- Understand design intent and operational impact
- Identify downstream CQV and operability risks early
- Influence design decisions constructively and pragmatically
- Experience optimising utilities designs to:
- Reduce CQV scope and redundancy
- Improve execution efficiency
- Protect schedule and long-term operability
- Background on large-scale CAPEX / new-build or major expansion projects
- Comfortable operating in a lean, fast-paced project environment
- Practical, value-driven mindset — focused on operability, robustness, and efficiency
Working Model
- Hybrid working model
- Approx. 50% on-site / 50% remote
Haider Tanveer
Principal Consultant
