Pharma Clean Utilities Engineer — WFI, Steam & GMP Systems

Wuxi Apptec, Inc.; Town of Middletown (NY); Vor Ort; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

Wuxi App Tec, Inc. seeks an Engineer of Pharmaceutical Clean Utilities to lead the design, deployment and maintenance of clean utilities including WFI systems, purified water, pure steam, clean air, nitrogen, and cleanroom HVAC within a GMP pharmaceutical facility.

The role covers lifecycle management, validation, and regulatory compliance, with cross-functional leadership across manufacturing operations. Responsibilities include system ownership, project execution, commissioning and validation,

Qualifikationen

• Bachelor's or Master's degree in Mechanical, Chemical, or Process Engineering required.
• 3–6+ years engineering or maintenance experience in cGMP pharma/biotech setting.
• Strong background in WFI technologies, P&ID reviews, RCA, and automation logic.

Aufgaben

• Own WFI, PW, PS, clean air, nitrogen, and cleanroom HVAC systems in a GMP facility.
• Lead design, budgeting, procurement, and construction for expansions or upgrades.
• Execute and approve DQ, FAT, SAT, IQ/OQ/PQ protocols per cGMP and ISPE/EU guidelines.
• Ensure hygienic design (ASME BPE, EHEDG) and compliance with FDA/EMA for sterile and non-sterile utilities.
• Monitor performance data, optimize uptime, and support predictive maintenance.

Kenntnisse

WFI tech

P&ID review

RCA

Automation logic

GMP compliance

Ausbildung

Engineering degree

Tools

PLC

SCADA

MES systems

BMS/EMS

Network design

Jobbeschreibung

Wuxi App Tec, Inc. seeks an Engineer of Pharmaceutical Clean Utilities to lead the design, deployment and maintenance of clean utilities including WFI systems, purified water, pure steam, clean air, nitrogen, and cleanroom HVAC within a GMP pharmaceutical facility.

The role covers lifecycle management, validation, and regulatory compliance, with cross-functional leadership across manufacturing operations. Responsibilities include system ownership, project execution, commissioning and validation,