Senior Facilities Engineer - GMP Utilities & CQV

Harba Solutions Inc.; Houston (TX); On-site; USD 85,000 - 110,000; Full time

Job summary

Harba Solutions Inc. is seeking a Facility Engineer in Houston, TX to design, operate, and maintain GMP-compliant facility systems. The role emphasizes reliability of HVAC, water systems, clean utilities, and energy efficiency to support regulated manufacturing.

The ideal candidate has a bachelor's in engineering, 3+ years in GMP facilities, and experience with CQV, audits, and CMMS tools such as Maximo or SAP PM. Strong collaboration with Quality, EHS, and Manufacturing is essential.

Qualifications

• Bachelor's degree in Mechanical, Electrical, Chemical, or Facilities Engineering is required.
• 3+ years of experience in facilities engineering within a GMP-regulated environment (pharma, biotech, or medical device).
• Working knowledge of cleanroom classifications, HVAC systems, 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 (e.g., Maximo, SAP PM).
• Excellent communication skills for cross-functional collaboration.

Responsibilities

• 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

Skills

3+ years experience in facilities eng

Strong troubleshooting & RCA

Cross-functional collaboration

Regulatory awareness (FDA/EMA/ISO)

Education

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

Tools

CMMS platforms (Maximo, SAP PM)

Job description

Harba Solutions Inc. is seeking a Facility Engineer in Houston, TX to design, operate, and maintain GMP-compliant facility systems. The role emphasizes reliability of HVAC, water systems, clean utilities, and energy efficiency to support regulated manufacturing.

The ideal candidate has a bachelor's in engineering, 3+ years in GMP facilities, and experience with CQV, audits, and CMMS tools such as Maximo or SAP PM. Strong collaboration with Quality, EHS, and Manufacturing is essential.