Lead Facilities Technician

Quality Agents, LLC; Gaithersburg (MD); On-site; USD 55,000 - 68,000; Full time

Benefits offered by this job

Health, dental and vision insurance

Life, AD&D and disability insurance

Health savings account

401k retirement plan

Paid time off

Paid holidays

Incentive bonuses

Job summary

Quality Agents, LLC provides validation and quality expertise to the pharmaceutical and biotechnology industries. The Lead Facilities Technician runs a 24-7 GMP biopharmaceutical facility, plans the shift, and acts as the first escalation point for alarms and equipment failures.

The role coordinates contractors and vendors and serves as the SME for site utility systems during investigations and audits while staying hands-on and ensuring SOPs and records are maintained to high standards.

Qualifications

• High school diploma or GED required.
• Able to work rotating shifts including nights, weekends and holidays.
• Valid driver’s license and transportation to the site.
• Experience with GMP mechanical, electrical and HVAC systems.
• Knowledge of cGMP, SOPs and Good Documentation Practices.

Responsibilities

• Lead the shift: plan, prioritize and assign daily work; ensure completion and documentation.
• Act as first escalation point for alarms and equipment failures; coordinate support and inform client management.
• Coordinate contractors, vendors and client teams for maintenance and emergencies.
• Serve as subject matter expert on utility systems for investigations and audits.
• Own SOPs, preventive maintenance tasks and shift work instructions; review records.
• Train and mentor technicians; identify recurring issues and improvement opportunities.

Skills

GMP systems

Mechanical systems

Electrical systems

HVAC systems

Clean utilities

CMMS

P&IDs reading

Electrical schematics

Single-line diagrams

Equipment manuals

Education

High school diploma or GED

Technical trade school

Associate degree in mechanical/electrical/HVAC

OSHA 30 certification

Tools

P&IDs

Electrical schematics

Single-line diagrams

Equipment manuals

Job description

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. Our facilities technicians operate and maintain the clean and plant utility systems, HVAC and building infrastructure that keep GMP manufacturing, laboratory and storage spaces running at client sites, around the clock where the site requires it. Technicians work to the client's SOPs, cGMP and Good Documentation Practices, and to current regulations and industry practice. Our mission is to provide cost-effective solutions by providing intelligent, driven resources to our clients, with superior quality and integrity.

The Role

The Lead Facilities Technician runs a shift of facilities technicians at a GMP biopharmaceutical manufacturing facility that runs 24-7. The Lead plans and assigns the shift's work, is the first escalation point for alarms, excursions and equipment failures, coordinates contractors and vendors, and is the day-to-day point of contact for the client's facility management on the shift. The Lead is the subject matter expert for the site's utility systems in investigations and audits and stays hands-on.

Responsibilities

Lead the shift

• Plan, prioritize and assign the daily work of the shift's technicians, and check that work is completed correctly, on time and documented.
• Act as the first escalation point for alarms, excursions and equipment failures on the shift: decide on containment, call in support and keep the client's facility management informed.
• Coordinate contractors, vendors and the client's engineering and automation teams for maintenance, repairs, shutdowns, investigations and emergencies.
• Serve as the subject matter expert on utility systems in deviation investigations and during internal, client and regulatory audits.
• Own the SOPs, preventive maintenance tasks and work instructions for the shift's systems and review the technicians' records.
• Train and mentor technicians; identify recurring failures, leaks, inefficiencies and improvement opportunities and bring them to the client's facility management.

Operate and maintain the utilities

• Operate and monitor purified water and WFI generation, storage and distribution systems (RO/EDI, distillation, storage tanks, hot loops, ozone and UV sanitization), and clean steam generators including steam quality parameters.
• Maintain compressed air and process gas systems (nitrogen, oxygen, carbon dioxide), including dryers, filters, manifolds and point-of-use assemblies.
• Monitor and maintain cleanroom HVAC: air handling units, HEPA filtration, differential pressure, temperature and humidity control.
• Operate the building management and environmental monitoring systems: respond to alarms, review data and record the actions taken.
• Maintain the chillers, boilers, plant steam, heating hot water, glycol and other plant utilities that supply the clean systems, and support the UPS, normal and emergency power systems.
• Respond to alarms and excursions, troubleshoot mechanical, electrical and controls faults, restore service and initiate deviations as required.

Keep the records and stay compliant

• Complete work orders, logbooks and preventive maintenance records in the site CMMS accurately and at the time of the work, following cGMP, SOPs and Good Documentation Practices.
• Support requalification, calibration and periodic review of utility systems, and the commissioning of utility changes.
• Take part 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 keep a clean, organized and safe work area.
• Comply with all applicable Quality Agents and client policies on health, safety and the environment.

What Good Looks Like

• The shift runs without surprises: alarms are answered, escalated when needed and closed with the client informed.
• The shift's records are audit-ready; technicians' work is checked and documented.
• Investigations reach real root causes and the CAPAs stick.
• The client's facility management trusts the Lead's updates and calls.
• Technicians on the shift get better at the job.

Skills

• Hands-on experience with GMP mechanical, electrical and HVAC systems and with clean utilities (purified water, WFI, clean steam, compressed air, 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.
• Troubleshooting across mechanical, electrical and controls systems, often 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.

Minimum Requirements

• High school diploma or GED.
• Able to work a rotating shift schedule including nights, weekends and holidays, and to take part in scheduled on-call rotations.
• Current driver's license and auto insurance, or other dependable means of transportation that allows you to reach 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.

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

Typical Experience

Typically, 7 or more years of hands-on facilities or utilities maintenance, including time in a GMP pharmaceutical or biotechnology manufacturing site, and experience leading or directing technicians. Experience ranges are a guide, not a requirement. Pay placement reflects experience and demonstrated performance.

Employment

Full-time, hourly, non-exempt, W-2. On site at a client biopharmaceutical manufacturing facility in Gaithersburg, MD. The facility operates 24-7: the role works a rotating shift schedule that includes nights, weekends and holidays, and takes part in scheduled on-call rotations. Overtime is paid for hours worked over 40 in a week.

Compensation and Benefits

Pay range: $40 to $49 per hour (about $83,200 to $101,900 per year at 2,080 hours), plus overtime. Placement within the range reflects experience and demonstrated skills.

Full-time employees are eligible for benefits 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

Incentive bonuses may be awarded depending on company profitability and individual contribution.

Benefits are subject to plan documents and eligibility requirements.

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.

Equal Opportunity & Accessibility Statement

Quality Agents, LLC is an equal opportunity employer. We make employment decisions without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, veteran status, or any other protected characteristic under applicable law. We are committed to providing reasonable accommodation for individuals with disabilities throughout the application and hiring process. If you require assistance or accommodation, please contact us.