Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries.
We are seeking a skilled and proactive Facilities/Utilities Engineer to support facility operations and critical utility systems in a regulated biotech environment. This role is responsible for ensuring the reliability, compliance, and efficiency of building infrastructure and utility systems that support GMP manufacturing, laboratory, and office spaces.
Key Responsibilities
• Oversee daily operations, maintenance, and troubleshooting of critical utilities including HVAC, clean steam, WFI, RO/DI water, compressed air, and nitrogen systems.
• Coordinate and manage vendors and service providers for scheduled maintenance, calibrations, and emergency repairs.
• Support commissioning, qualification (IQ/OQ), and validation of utility systems and facility expansions or modifications.
• Maintain and update engineering documentation such as P&IDs, SOPs, URSs, and maintenance logs.
• Ensure facility systems are compliant with GMP, FDA, and other applicable regulatory standards.
• Collaborate with Manufacturing, QA, EHS, and Engineering to support operational readiness and ongoing facility improvements.
• Lead or support deviation investigations and implement corrective and preventive actions (CAPAs) related to utility systems.
Minimum Requirements:
• B.S. in Mechanical Engineering, Chemical Engineering, Facilities Engineering, or a related field.
• 3+ years of experience in a biotech, pharmaceutical, or GMP-regulated manufacturing facility.
• Strong knowledge of clean utility systems, building automation systems (BAS), and GMP facility operations.
• Experience with commissioning/qualification protocols and regulatory compliance standards.
• Excellent organizational, troubleshooting, and communication skills.
Quality Agents offers a full suite of benefits for full-time employees including:
• Health, dental and vision insurance
• Life, AD&D and Disability Insurance
• Health savings account for participants in our health plan
• 401k retirement plan
• Paid time off
• Paid holidays
Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.
Quality Agents