Lead Facilities Technician

Quality Agents • Gaithersburg, MD

2d • $40 - $49 • Onsite

About The Position

Quality Agents, LLC provides validation and quality expertise to the pharmaceutical and biotechnology industries. Its facilities technicians operate and maintain clean and plant utility systems, HVAC, and building infrastructure supporting GMP manufacturing, laboratory, and storage spaces at client sites. Work follows client SOPs, cGMP, Good Documentation Practices, applicable regulations, and industry practices.

The Lead Facilities Technician leads a shift of facilities technicians at an on-site GMP biopharmaceutical manufacturing facility operating 24-7. The Lead plans and assigns 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 a subject matter expert on site utility systems during investigations and audits.

This is a full-time, hourly, non-exempt W-2 position. The role follows a rotating shift schedule that includes nights, weekends, and holidays, and participates in scheduled on-call rotations. Overtime is paid for hours worked over 40 in a week. The position is on site at a client biopharmaceutical manufacturing facility in Gaithersburg, Maryland. Pay is $40 to $49 per hour, approximately $83,200 to $101,900 per year at 2,080 hours, plus overtime. Pay placement reflects experience and demonstrated skills.

Full-time employees are eligible for health, dental, and vision insurance; life, AD&D, and disability insurance; a health savings account for health-plan participants; a 401k retirement plan; paid time off; and paid holidays. Incentive bonuses may be awarded depending on company profitability and individual contribution. Benefits are subject to plan documents and eligibility requirements. Applications are accepted on an ongoing basis and remain under consideration as positions become available for one year from the application date.

Requirements

• High school diploma or GED.
• 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, often with limited standardization.
• Working knowledge of cGMP, including 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 that allows 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.
• Typically, seven or more years of hands-on facilities or utilities maintenance, including time at a GMP pharmaceutical or biotechnology manufacturing site, and experience leading or directing technicians. The experience range is a guide, not a requirement.

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 the shift's daily work, and check that technicians complete work correctly, on time, and with proper documentation.
• 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 shift SOPs, preventive maintenance tasks, and work instructions, and review technicians' 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, as well as clean steam generators and 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, and support UPS, normal power, and emergency power systems.
• 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 contemporaneously in accordance with cGMP, SOPs, and Good Documentation Practices.
• Support requalification, calibration, periodic review of utility systems, 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.
• 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.
• Work a rotating schedule including nights, weekends, and holidays, and participate in scheduled on-call rotations.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• Life, AD&D, and disability insurance
• Health savings account for participants in the company's health plan
• 401k retirement plan
• Paid time off
• Paid holidays
• Possible incentive bonuses based on company profitability and individual contribution

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED