Clean Utilities Engineer (Pharmaceutical)

Location: Middletown, Delaware, US; on-site work in office and GMP production environments, with access to mechanical spaces, PPE use, lifting up to 25 lbs, and occasional off-shift work for commissioning or troubleshooting.

Company

hirify.global operates a GMP-compliant pharmaceutical manufacturing facility.

What you will do

• Own the lifecycle of WFI, purified water, pure steam, clean compressed air, clean nitrogen generation and distribution loops, and cleanroom HVAC systems.
• Lead design, budgeting, procurement, construction, system integration, and equipment upgrade projects.
• Execute and approve DQ, FAT, SAT, and IQ/OQ/PQ activities using risk-based and science-based commissioning and qualification approaches.
• Maintain cGMP, FDA, EMA, EU GMP Annex 1, contamination control, hygienic design, and data integrity compliance.
• Investigate clean utility deviations and root causes, and support regulatory audits.
• Monitor performance data, optimize uptime, and support predictive maintenance.

Requirements

• Bachelor’s or Master’s degree in Mechanical, Chemical, or Process Engineering.
• 3 to 6+ years of engineering or maintenance experience within a cGMP-regulated pharmaceutical or biotech setting.
• Strong background in thermal or membrane WFI technologies, P&ID reviews, root cause analysis, and automation logic.
• Expertise in managing validated systems and supporting regulatory audits.
• Proficiency in PLC, SCADA, BMS/EMS, MES systems, and network architecture.
• Proficiency in cGMP, GAMP5, 21 CFR Part 11, and data integrity principles.
• Strong organizational, analytical, technical problem-solving, verbal, and written communication skills.
• Hands-on leadership experience, including team development, cross-functional collaboration, and strategic initiative leadership.
• Ability to work in office and GMP production environments, wear PPE, access mechanical spaces, lift up to 25 lbs, and work occasional off-shift hours.

Culture & Benefits

• Cross-functional work across manufacturing operations, quality, engineering, and maintenance.
• Hands-on leadership and strategic initiative ownership.
• Work in a GMP-regulated pharmaceutical manufacturing environment.