Facilities Technician

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 Facilities Technician operates, monitors and maintains the utility and facility systems of a GMP biopharmaceutical manufacturing facility that runs 24-7. The Technician works within a shift team under a Lead Facilities Technician, resolves alarms and routine issues independently, and documents all work to GMP standards. The role carries no supervisory responsibility.

Responsibilities

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.
• Perform rounds of mechanical rooms, utility spaces, cleanrooms, rooftops and cold storage to identify abnormal conditions before they become alarms.
• Perform routine sanitization, passivation support and filter changes per approved procedures.
• 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.
• Coordinate contractor work in GMP areas with proper gowning, permitting and oversight.
• 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

• Utility systems run within their limits; alarms are answered quickly, resolved and recorded.
• Work orders, logbooks and PM records are complete, accurate and right first time.
• Procedures are followed, and anything outside them is raised as a deviation, not worked around.
• Dependable on shift, on weekends and holidays, and on call.
• Works well with the shift team, the client's engineering staff and contractors.

Skills

• Hands-on experience with GMP mechanical, electrical and HVAC systems. Experience with clean utilities (purified water, WFI, clean steam, compressed air, process gases) is strongly desired.
• Ability to read P&IDs, electrical schematics and equipment manuals.
• Working knowledge of CMMS and building management or environmental monitoring platforms.
• Troubleshooting across mechanical, electrical and controls systems.
• Familiarity with cGMP (21 CFR Parts 210 and 211), Good Documentation Practices and USP <1231> water quality requirements, or the ability to learn them quickly.
• Clear written and verbal communication, including complete and legible records.

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 electrician or HVAC license, or OSHA 10 or 30.
• Experience with deviations, change control or regulated investigations.

Typical Experience

Typically, 2 to 7 years of hands-on facilities or utilities maintenance, with time in a GMP pharmaceutical, biotechnology or other regulated manufacturing site preferred. 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: $34 to $42 per hour (about $70,700 to $87,400 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.