Utilities/Facilities Engineer

Quality Agents; Rockville (MD); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

AD&D insurance

401k retirement plan

Paid time off

Paid holidays

Job summary

Quality Agents, LLC is seeking a skilled Facilities/Utilities Engineer to support biotech facility operations in Rockville, MD. The role covers HVAC, clean utilities, and compliance within a regulated GMP environment.

You will collaborate with Manufacturing, QA, EHS, and Engineering to ensure readiness and ongoing facility improvements, while supporting commissioning and validation activities.

Qualifications

• BS in Mechanical Engineering, Chemical Engineering, Facilities Engineering, or related field.
• 3+ years in biotech, pharmaceutical, or GMP-regulated manufacturing facility.
• Strong knowledge of clean utility systems, BAS, and GMP facility operations.
• Experience with commissioning/qualification protocols and regulatory standards.

Responsibilities

• Oversee daily operations, maintenance, and troubleshooting of critical utilities including HVAC, clean steam, WFI, RO/DI water, compressed air, and nitrogen systems.
• Coordinate vendors and service providers for maintenance, calibrations, and emergency repairs.
• Support commissioning, 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 for readiness and facility improvements.
• Lead or support deviation investigations and CAPAs related to utility systems.

Skills

GMP facility operations

Troubleshooting

Vendor management

Commissioning/IQ-OQ

Documentation

Education

B.S. in Mechanical Engineering, Chemical Engineering, Facilities Engineering, or related field

Tools

Building Automation Systems (BAS)

Job description

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.