Biotech GMP 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 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.