GMP Facilities Engineer – Critical Utilities & CQV

Harba Solutions Inc.; North Carolina; Sur place; USD 95 000 - 125 000; Plein temps

Résumé du poste

Harba Solutions Inc. is seeking a Facility Engineer to lead design, operation, and continuous improvement of facility systems supporting GMP manufacturing. You will ensure HVAC, water systems, clean steam, and process utilities operate reliably and in compliance with regulatory standards.

The role requires CQV involvement, deviation handling with QA, and driving preventive maintenance and energy efficiency improvements. Strong troubleshooting and cross-functional collaboration are essential.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Chemical, or Facilities Engineering (or related field).
• 3+ years of facilities engineering experience in a GMP-regulated environment.
• Working knowledge of cleanroom classifications, HVAC, and critical utility systems.
• Familiarity with FDA, EMA, and ISO regulatory frameworks.
• Experience with CQV protocols and documentation.
• Strong troubleshooting and root cause analysis skills.
• Proficiency with CMMS platforms (Maximo, SAP PM).

Responsabilités

• Manage and maintain critical facility systems including HVAC, purified water, WFI, clean steam, compressed air, and process gases
• Support commissioning, qualification, and validation (CQV) activities for new and existing facility equipment and systems
• Troubleshoot mechanical, electrical, and control system issues affecting cleanrooms and production areas
• Ensure facility systems remain in compliance with cGMP, FDA, and other applicable regulatory requirements
• Partner with Quality, EHS, and Manufacturing teams on deviations, CAPAs, and change controls related to facility systems
• Develop and maintain preventive maintenance programs for facility equipment
• Support facility expansion, retrofit, and capital improvement projects
• Review and update SOPs, drawings, and documentation related to facility operations
• Participate in risk assessments and support audits (internal and regulatory)
• Monitor energy usage and recommend efficiency improvements

Connaissances

Troubleshooting

Communication

Root cause analysis

Formation

Bachelor's degree in Mechanical, Electrical, Chemical, or Facilities Engineering

Outils

Maximo

SAP PM

Description du poste

Harba Solutions Inc. is seeking a Facility Engineer to lead design, operation, and continuous improvement of facility systems supporting GMP manufacturing. You will ensure HVAC, water systems, clean steam, and process utilities operate reliably and in compliance with regulatory standards.

The role requires CQV involvement, deviation handling with QA, and driving preventive maintenance and energy efficiency improvements. Strong troubleshooting and cross-functional collaboration are essential.