Lead 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 Lead Facilities Technician runs a shift of facilities technicians at an on-site GMP biopharmaceutical manufacturing facility operating 24-7. The Lead plans and assigns shift work, serves as the first escalation point for alarms, excursions, and equipment failures, coordinates contractors and vendors, and acts as the shift's day-to-day contact for the client's facility management. The role is hands-on and serves as the subject matter expert for the site's utility systems during investigations and audits. The position operates and maintains clean and plant utility systems, HVAC, and building infrastructure supporting GMP manufacturing, laboratory, and storage spaces. Systems include purified water and WFI, clean steam, compressed air and process gases, cleanroom HVAC, building management and environmental monitoring systems, chillers, boilers, plant steam, heating hot water, glycol, and power systems. Work is performed according to client SOPs, cGMP, Good Documentation Practices, applicable regulations, and industry practice. The Lead keeps work orders, logbooks, and preventive maintenance records accurate and audit-ready; supports requalification, calibration, commissioning, investigations, root cause analysis, CAPA, and change control; and ensures technicians are trained and their work is checked. The role requires a rotating schedule including nights, weekends, and holidays, plus scheduled on-call rotations. It is full-time, hourly, non-exempt, W-2 employment at a client facility in Gaithersburg, Maryland. The pay range is $40 to $49 per hour, plus overtime for hours worked over 40 in a week.

Requirements

High school diploma or GED.
Typically, 7 or more years of hands-on facilities or utilities maintenance experience, including experience at a GMP pharmaceutical or biotechnology manufacturing site and experience leading or directing technicians; the stated experience range is a guide, not a requirement.
Hands-on experience with GMP mechanical, electrical, and HVAC systems and clean utilities, including purified water, WFI, clean steam, compressed air, and process gases.
Experience leading or directing technicians on a shift and coordinating contractors and vendors.
Ability to read P&IDs, electrical schematics, single-line diagrams, and equipment manuals.
Working knowledge of CMMS and building management or environmental monitoring platforms.
Ability to troubleshoot mechanical, electrical, and controls systems, including in settings with limited standardization.
Working knowledge of cGMP (21 CFR Parts 210 and 211), Good Documentation Practices, and USP <1231> water quality requirements.
Experience with deviations, change control, and CAPA.
Clear written and verbal communication with technicians, contractors, and client management.
Ability to work a rotating shift schedule including nights, weekends, and holidays, and participate in scheduled on-call rotations.
Current driver's license and auto insurance, or another dependable means of transportation allowing arrival at the site within about two hours when on call.
Ability 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.

Nice To Haves

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 or master electrician license, or OSHA 30.
Experience hosting or supporting client and regulatory audits of utility systems.

Responsibilities

Plan, prioritize, and assign daily work to the shift's technicians; verify that work is completed correctly, on time, and documented.
Respond as the shift's first escalation point for alarms, excursions, and equipment failures; determine containment, call in support, and keep client facility management informed.
Coordinate contractors, vendors, and client engineering and automation teams for maintenance, repairs, shutdowns, investigations, and emergencies.
Serve as the utility systems subject matter expert in deviation investigations and internal, client, and regulatory audits.
Own and review shift SOPs, preventive maintenance tasks, work instructions, and technician records.
Train and mentor technicians; identify recurring failures, leaks, inefficiencies, and improvement opportunities and raise them with client facility management.
Operate and monitor purified water and WFI generation, storage, and distribution systems, including RO/EDI, distillation, storage tanks, hot loops, ozone, and UV sanitization.
Operate clean steam generators and monitor steam quality parameters.
Maintain compressed air and process gas systems, including nitrogen, oxygen, carbon dioxide, 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 control.
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; support UPS, normal power, and emergency power systems.
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 contemporaneously, following cGMP, SOPs, and Good Documentation Practices.
Support utility system requalification, calibration, periodic review, 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; support change controls for utility modifications.
Follow EHS policies, including lockout/tagout, confined space, hot work, permit-to-work, and chemical handling, and maintain a clean, organized, and safe work area.
Comply with applicable Quality Agents and client health, safety, and environmental policies.

Benefits

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