Utilities SME

i‑Pharm Consulting; Philadelphia (Philadelphia County); Hybrid; GBP 125,000 - 208,000; Full time

Job summary

i-Pharm Consulting seeks an experienced Utilities SME Consultant to support a large GMP CAPEX programme in Philadelphia. The role covers design review, CQV readiness, and a seamless transition to operations for critical clean and black utilities.

The role requires working within a lean project team, identifying operability risks early, and influencing design decisions to accelerate commissioning, testing, and start-up across WFI, PW, clean steam, CIP/SIP, HVAC, and related interfaces.

Qualifications

• Senior-level Utilities SME background in GMP manufacturing.
• Experience with clean and black utilities systems and GMP utilities design, operation, and qualification.
• Ability to identify downstream CQV and operability risks early and influence design decisions pragmatically.

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.
• Address HVAC interfaces (GMP and non-GMP) and overall utilities integration.
• Perform detailed design and documentation reviews with a CQV and operability focus.
• Collaborate with Utilities & Process Engineering, CQV teams, Capital Projects, QA and Engineering stakeholders.
• Provide pragmatic input to reduce CQV scope and rework and accelerate readiness for start-up and operations.

Skills

Utilities SME

GMP manufacturing

Clean utilities

Black utilities

CQV readiness

Design review

Operability risk

Stakeholder collaboration

Job description

• 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:

• 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
• 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
• 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
• Reduce CQV scope and redundancy
• 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
• Philadelphia, Pennsylvania, United States