Quality Technician Jobs

About The Position

Requirements

• High school diploma or GED.
• Hands-on experience with GMP mechanical, electrical, and HVAC systems.
• Ability to read P&IDs, electrical schematics, and equipment manuals.
• Working knowledge of CMMS and building management or environmental monitoring platforms.
• Ability to troubleshoot mechanical, electrical, and controls systems.
• Familiarity with cGMP (21 CFR Parts 210 and 211), Good Documentation Practices, and USP <1231> water quality requirements, or ability to learn them quickly.
• Clear written and verbal communication, including the ability to produce complete and legible records.
• Able to work a rotating shift schedule that includes nights, weekends, and holidays, and participate in scheduled on-call rotations.
• Current driver's license and auto insurance, or other dependable transportation that allows arrival at 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.
• Typically 2 to 7 years of hands-on facilities or utilities maintenance experience; experience ranges are a guide, not a requirement.

Nice To Haves

• Experience with clean utilities, including purified water, WFI, clean steam, compressed air, and process gases.
• Experience at a GMP pharmaceutical, biotechnology, or other regulated manufacturing site.
• 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.

Responsibilities

• Operate and maintain purified water and WFI generation, storage, and distribution systems, including RO/EDI, distillation, storage tanks, hot loops, ozone, and UV sanitization, and clean steam generators and their steam quality parameters.
• Maintain compressed air and process gas systems, including nitrogen, oxygen, and carbon dioxide systems, 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.
• Perform rounds of mechanical rooms, utility spaces, cleanrooms, rooftops, and cold storage to identify abnormal conditions.
• Perform routine sanitization, passivation support, and filter changes according to approved procedures.
• 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 at the time of work, 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.
• Coordinate contractor work in GMP areas, ensuring proper gowning, permitting, and oversight.
• Follow EHS policies, including lockout/tagout, confined space, hot work, permit-to-work, and chemical handling requirements; maintain a clean, organized, and safe work area.
• Comply with applicable Quality Agents and client health, safety, and environmental policies.
• Work dependably on shift, including weekends and holidays, and participate in scheduled on-call rotations; collaborate with the shift team, client engineering staff, and contractors.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• Life, AD&D, and disability insurance
• Health savings account for health-plan participants
• 401(k) retirement plan
• Paid time off
• Paid holidays
• Possible incentive bonuses based on company profitability and individual contribution
• Overtime pay for hours worked over 40 in a week