GMP Utilities SME: Design & CQV Readiness Expert

i‑Pharm Consulting; Philadelphia (Philadelphia County); Híbrido; GBP 125.000 - 208.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Utilities SME

GMP manufacturing

Clean utilities

Black utilities

CQV readiness

Design review

Operability risk

Stakeholder collaboration

Descripción del empleo

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.