Facilities Technician

Quality Agents•Gaithersburg, MD

1d•Onsite

About The Position

Quality Agents, LLC provides validation and quality expertise to the pharmaceutical and biotechnology industries. The Facilities Technician operates, monitors, and maintains utility and facility systems at a GMP biopharmaceutical manufacturing facility, including clean and plant utilities, HVAC, and building infrastructure. The site operates 24-7, and the Technician works on a rotating shift team under a Lead Facilities Technician. The role has no supervisory responsibility and requires independent resolution of alarms and routine issues, with all work documented to GMP standards. The Technician maintains systems supporting GMP manufacturing, laboratory, and storage spaces, following client SOPs, cGMP, Good Documentation Practices, current regulations, and industry practices. Duties include operating clean utility systems; maintaining plant equipment and HVAC; responding to alarms and excursions; completing maintenance and compliance documentation; supporting requalification, calibration, commissioning, investigations, and change controls; coordinating contractor work; and following safety requirements. This is a full-time, hourly, non-exempt W-2, onsite role at a client facility in Gaithersburg, Maryland. The schedule rotates and includes nights, weekends, and holidays, with scheduled on-call rotations. Overtime is paid for hours worked over 40 in a week. Pay is $34–$42 per hour, approximately $70,700–$87,400 annually at 2,080 hours, plus overtime. Benefits-eligible full-time employees may receive health, dental, vision, life, AD&D and disability insurance, a health savings account for health-plan participants, a 401(k), paid time off, and paid holidays. Incentive bonuses may be awarded based on company profitability and individual contribution; benefits are subject to plan documents and eligibility requirements.

Requirements

High school diploma or GED.
Typically 2 to 7 years of hands-on facilities or utilities maintenance experience; experience ranges are a guide, not a requirement.
Able to work a rotating shift schedule that includes nights, weekends, and holidays, and participate in scheduled on-call rotations.
Current driver's license and auto insurance, or another dependable means of transportation that allows arrival at the site within about two hours when on call.
Able to stand and walk for long periods, climb ladders and stairs, lift up to 50 pounds, and work in varying temperatures and noise levels while wearing PPE, including cleanroom gowning.
Hands-on experience with GMP mechanical, electrical, and HVAC systems.
Ability to read P&IDs, electrical schematics, and equipment manuals.
Working knowledge of CMMS and building management or environmental monitoring platforms.
Troubleshooting ability across mechanical, electrical, and controls systems.
Clear written and verbal communication, including complete and legible records.
Follow client SOPs, cGMP, Good Documentation Practices, and applicable regulations and safety procedures.

Nice To Haves

Experience with clean utilities, including purified water, WFI, clean steam, compressed air, and process gases, is strongly desired.
Experience in a GMP pharmaceutical, biotechnology, or other regulated manufacturing site is preferred.
Technical trade school, military training, or an associate degree in mechanical, electrical, HVAC, or a related field.
Maryland Stationary Engineer license, boiler operator license, EPA Section 608 certification, Maryland journeyman electrician or HVAC license, or OSHA 10 or 30.
Experience with deviations, change control, or regulated investigations.
Familiarity with cGMP (21 CFR Parts 210 and 211), Good Documentation Practices, and USP <1231> water quality requirements, or ability to learn them quickly.

Responsibilities

Operate and maintain purified water and WFI generation, storage, and distribution systems, including RO/EDI, distillation, storage tanks, hot loops, ozone, and UV sanitization, as well as clean steam generators and steam quality parameters.
Maintain compressed air and process gas systems, including nitrogen, oxygen, and carbon dioxide systems, dryers, filters, manifolds, and point-of-use assemblies.
Monitor and maintain cleanroom HVAC systems, including air handling units, HEPA filtration, differential pressure, temperature, and humidity controls.
Operate building management and environmental monitoring systems, respond to alarms, review data, and record actions taken.
Maintain chillers, boilers, plant steam, heating hot water, glycol, and other plant utilities, and support UPS, normal power, and emergency power systems.
Conduct rounds of mechanical rooms, utility spaces, cleanrooms, rooftops, and cold storage to identify abnormal conditions.
Perform routine sanitization, passivation support, and filter changes according to approved procedures.
Respond to alarms and excursions; troubleshoot mechanical, electrical, and controls faults; restore service; and initiate deviations as required.
Complete work orders, logbooks, and preventive maintenance records in the site CMMS accurately and promptly, following cGMP, SOPs, and Good Documentation Practices.
Support utility-system requalification, calibration, periodic reviews, and commissioning of utility changes.
Participate in deviation investigations, root cause analysis, and CAPA implementation.
Draft and revise SOPs, preventive maintenance tasks, and work instructions, and support change controls for utility modifications.
Coordinate contractor work in GMP areas, ensuring appropriate gowning, permits, and oversight.
Follow EHS policies, including lockout/tagout, confined space, hot work, permit-to-work, and chemical handling requirements; maintain a clean, organized, and safe work area.
Comply with applicable Quality Agents and client health, safety, and environmental policies.
Work dependably on shift, weekends, and holidays, and participate in scheduled on-call rotations.

Benefits

Health insurance
Dental insurance
Vision insurance
Life insurance
AD&D insurance
Disability insurance
Health savings account for health-plan participants
401(k) retirement plan
Paid time off
Paid holidays
Incentive bonuses may be awarded depending on company profitability and individual contribution
Overtime pay for hours worked over 40 in a week