GMP Utilities Shift Lead — 24/7 Facilities Expert

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 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.