Clean Room Certification Technician in Lansdale, Pennsylvania at QUANTUS INC

Company Description: Quantus, Inc. is a Pennsylvania Corporation operating in the Life Sciences Equipment Services Industry. Our Customers operate facilities and manufacture product regulated by the FDA, ISO, EMA and other national and international regulatory bodies. We specialize in providing onsite Calibration, Certification, Consulting & Staffing, Environmental Monitoring, and Validation Services at our customers’ facilities located throughout the Mid-Atlantic Region (namely: DE, MD, NJ, PA, VA) for routine services and project services (namely Validation) requires travel nationally to support customers with multiple locations.

Job Description

As a Cleanroom & HEPA Certification Technician at Quantus, Inc., you will support the delivery of onsite cleanroom and HEPA equipment certification services at pharmaceutical, biotech, compounding pharmacy, and medical device facilities throughout the Mid-Atlantic region. Working alongside our NSF-accredited and NEBB-certified certification team, you will assist in performing testing and certification services on cleanrooms, biological safety cabinets (BSCs), laminar flow hoods, fume hoods, and a wide range of HEPA-filtered equipment — ensuring our customers' controlled environments meet the safety, quality, and regulatory compliance standards required by their operations. This is an excellent entry point into one of the life sciences industry's most specialized and in-demand technical service areas.

As a CERTIFICATION TECHNICIAN, you will report to the Certification Department Manager, and your job duties generally will entail the following:

• Support the certification team in performing onsite certification services on cleanrooms, biological safety cabinets (BSCs), laminar flow hoods, fume hoods, and HEPA-filtered equipment in accordance with Quantus SOPs, customer procedures, and applicable regulatory standards
• Assist in performing HEPA filter integrity testing, airflow velocity testing, smoke pattern testing, and particle count testing on controlled environment equipment including cleanrooms, BSCs, laminar flow benches and hoods, PCR hoods, weigh booths, glove boxes, isolators, bag-in/bag-out units, and HEPA filter banks
• Support fume hood certification services including airflow velocity and smoke pattern testing in compliance with ANSI, ASHRAE 110, NEBB, OSHA, and SEFA standards
• Assist in preparing detailed certification reports documenting test results for customer review; ensure all documentation follows Good Documentation Practices (GDP) and applicable regulatory standards
• Support identification of deviations from established certification acceptance criteria; assist the Specialist in documenting deviation reports and recommending appropriate corrective actions in coordination with the customer
• Adhere to Quantus SOPs, customer-specific procedures, and all applicable regulatory standards including ISO 14644, USP 797, EU Annex 1, and CETA CAG-003 on every customer site visit
• Maintain a professional, customer-focused presence at all times; build customer relationships by offering assistance beyond the immediate task list and leveraging Quantus's technical expertise to support customers' certification and compliance programs
• Provide additional technical support in calibration services as assigned, supporting cross-functional service delivery at customer sites
• Comply with all Safety Sensitive standards; maintain the full, unimpaired skills and judgment required for safe execution of certification services
• Complete all required training and qualification programs including NEBB certification training as provided by Quantus
• Maintain company-provided fleet vehicle in accordance with Quantus fleet policies; depart from home directly to customer sites

The job requirements for this position are as follows:

• 0-2 years of experience in cleanroom certification, HEPA filtration testing, BSC certification, controlled environment testing, or related life sciences field technical services; strong mechanical aptitude and familiarity with regulated environments considered in lieu of direct experience
• Familiarity with controlled environment concepts and the principles of HEPA filtration, cleanroom classification, and contamination control a plus
• Knowledge of or exposure to regulatory standards applicable to cleanroom and controlled environment certification (ISO 14644, USP797, EU Annex 1) preferred
• Strong attention to detail and commitment to documentation accuracy and Good Documentation Practices
• Strong interpersonal and communication skills; professional customer-facing demeanor required
• Ability to move efficiently between task types, follow detailed procedures precisely, and demonstrate initiative in a field service environment
• Must be computer literate, proficient in Microsoft Office and email, and able to learn and work within custom database and reporting applications
• Ability to lift up to 50 lbs and perform field work at customer sites including bending, kneeling, sitting, and standing; work in cleanroom and controlled environments requiring gowning
• Compliance with Safety Sensitive standards; must possess full, unimpaired skills and judgment for safe job execution
• Valid driver's license and clean driving record required; company fleet vehicle provided, technicians depart from home
• Local and regional travel to customer sites throughout the Mid-Atlantic region
• Must be able to pass a drug and background check