Pharma Clean Utilities Engineer - GMP Compliance Lead

WuXi AppTec Group

Town of Middletown (NY)

On-site

USD 110,000 - 160,000

Full time

10 days ago

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Job summary

WuXi AppTec Group seeks an Engineer of Pharmaceutical Clean Utilities to lead the design, deployment, and maintenance of WFI and PW systems, pure steam, clean air, nitrogen, and cleanroom HVAC within a GMP facility. You will drive project execution, validation, and regulatory alignment across multiple utilities.

The role demands strong background in WFI tech, P&ID reviews, RCA and automation, plus PLC/SCADA and MES experience.

Qualifications

Bachelor’s or Master’s degree in Mechanical, Chemical, or Process Engineering.
3 to 6+ years of engineering or maintenance experience in a cGMP pharmaceutical or biotech setting.
Strong background in WFI technologies, P&ID reviews, RCA, and automation logic.
Experience managing validated systems and supporting regulatory audits.
Proficient in PLC, SCADA, BMS/EMS, MES systems and network architecture.

Responsibilities

System Ownership: manage WFI, PW, PS, clean air/gas loops and cleanroom HVAC per regulatory standards.
Project Execution: lead design, budget, procurement, and construction for expansions or upgrades.
Commissioning & Validation: execute DQ, FAT, SAT, IQ/OQ/PQ per cGMP and ASTM E2500.
Compliance & Quality: uphold hygienic design and align with FDA/EMA guidelines; CCS coordination.
Reliability & Maintenance: monitor data, optimize uptime, support predictive maintenance.