Clean Utilities Engineer

WuXi AppTec • Middletown, DE

3d

About The Position

The Clean Utilities Engineer leads the design, deployment, maintenance, integration, validation, and operational compliance of clean utility systems in a GMP-compliant pharmaceutical manufacturing facility. Systems include purified water and WFI, pure steam, clean compressed air, nitrogen generation and distribution, and cleanroom HVAC. The role leads cross-functional efforts to implement solutions that support quality, compliance, efficiency, and manufacturing scalability.

The engineer owns clean utility systems in accordance with applicable regulations, cGMP requirements, and referenced industry standards. The role also leads facility expansion and equipment upgrade projects, including design, budgeting, procurement, and construction; executes and approves commissioning and qualification activities; supports quality investigations and root-cause analysis; and monitors system performance to optimize uptime and support predictive maintenance.

The position requires work in office and GMP production environments, the ability to wear PPE and access mechanical spaces when needed, and may involve lifting up to 25 pounds and occasional off-shift work for commissioning or troubleshooting. Other job-related duties may be assigned by management.

Requirements

• Bachelor’s or Master’s degree in Mechanical, Chemical, or Process Engineering.
• 3 to 6+ years of engineering or maintenance experience in a cGMP-regulated pharmaceutical or biotech setting.
• Strong background in thermal or membrane WFI technologies, P&ID reviews, root-cause analysis, and automation logic.
• Demonstrated expertise managing validated systems and supporting regulatory audits.
• Proficiency with PLC, SCADA, BMS/EMS, MES systems, and network architecture.
• Strong organizational, analytical, and technical problem-solving skills.
• Excellent verbal and written communication skills.
• Hands-on leadership style and experience in team development.
• Ability to work cross-functionally and lead strategic initiatives.
• Proficiency in cGMP, GAMP5, 21 CFR Part 11, and data integrity principles.
• Ability to work in office and GMP production environments, wear PPE, and access mechanical spaces when necessary.
• Ability to lift up to 25 pounds; occasional off-shift work may be required for system commissioning or troubleshooting.

Responsibilities

• Manage WFI, purified water, pure steam, clean compressed air, clean nitrogen generation and distribution loops, and cleanroom HVAC systems in compliance with local regulations and cGMP requirements and applicable standards.
• Lead design, budgeting, procurement, and construction phases for facility expansions and equipment upgrades.
• Execute and approve DQ, FAT, SAT, and IQ/OQ/PQ protocols in accordance with cGMP standards, ASTM E2500, and ISPE guidance.
• Establish a risk-based, science-based commissioning and qualification approach rather than relying on the traditional DQ/IQ/OQ/PQ model.
• Maintain hygienic design practices and align clean utility systems with FDA and EMA guidelines for non-sterile and sterile applications.
• Plan and execute activities to meet EU GMP Annex 1 requirements in coordination with the Contamination Control Strategy for critical utilities.
• Investigate clean utility system issues and lead deviation and root-cause processes in accordance with site procedures.
• Monitor performance data, optimize operational uptime, and support predictive maintenance routines.
• Lead cross-functional efforts to implement solutions that advance quality, compliance, efficiency, and manufacturing scalability.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level