Certification Tech

Ellab-Inc

Cambridge (MA)

On-site

USD 85,000 - 120,000

Full time

6 days ago
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Job summary

Ellab-Inc in Cambridge, MA, seeks an experienced field service professional to lead certification and calibration of biosafety cabinets and lab hoods.

You will perform independent BSC certification (Class I and II), fume hood testing, and HEPA verification, supporting GMP/GxP environments and documenting results.

The role emphasizes hands-on testing, troubleshooting, and accurate report generation in regulated pharma/biotech settings.

Qualifications

  • 3–5 years of experience performing certification, calibration, or field service in regulated environments.
  • Ability to independently certify Biosafety Cabinets (Class I and II).
  • Experience testing chemical fume hoods, including face velocity and containment testing.
  • Working knowledge of NSF/ANSI 49, ASHRAE 110, and regulatory requirements.
  • Proficient with airflow velocity, inflow/outflow, and smoke visualization testing.
  • Experience with HEPA filter integrity/leak testing using aerosol generators and photometers.
  • Familiar with test equipment: anemometers, photometers, manometers, particle counters.
  • Able to perform functional testing, adjustment, troubleshooting, and minor repairs of BSCs and hoods.
  • Experience calibrating temperature, humidity, pressure, and airflow in labs.
  • Knowledge of GMP/GxP and GDP in pharma/biotech environments.
  • Ability to interpret procedures, drawings, and acceptance criteria.
  • Ability to troubleshoot airflow, containment, and instrumentation issues.
  • Ability to complete certification reports and test data to quality standards.
  • Technical training or degree in metrology, instrumentation, HVAC, or related field preferred.

Skills

BSC certification
Fume hood testing
NSF/ANSI 49
ASHRAE 110
Regulatory compliance
Airflow testing
HEPA testing
Instrumentation testing
Troubleshooting repair
Metrology background
GMP/GxP knowledge
Documentation
Certification testing
Calibrations

Job description

  • 3–5 years of experience performing certification, calibration, or field service activities in pharmaceutical, biotechnology, laboratory, or other regulated environments.
  • Demonstrated ability to independently perform Biosafety Cabinet (BSC) certification, including Class I and Class II cabinets.
  • Demonstrated ability to perform chemical fume hood testing and certification, including face velocity, airflow uniformity, and containment/visualization testing.
  • Working knowledge of applicable industry standards, including NSF/ANSI 49, ASHRAE 110, manufacturer specifications, and applicable regulatory requirements.
  • Proficient in airflow velocity, inflow/downflow, smoke visualization, airflow pattern, and containment testing.
  • Experience performing HEPA filter integrity/leak testing using aerosol generators, photometers, and related test equipment.
  • Proficient with certification and measurement equipment including anemometers, photometers, aerosol generators, manometers, particle counters, and airflow capture devices.
  • Ability to perform functional testing, adjustment, troubleshooting, and minor repair of BSCs, fume hoods, and associated airflow/containment systems.
  • Experience performing calibrations of common laboratory instrumentation, including temperature, humidity, pressure, differential pressure, and airflow.
  • Working knowledge of GMP/GxP requirements and Good Documentation Practices (GDP) applicable to pharmaceutical and biotechnology environments.
  • Ability to interpret technical procedures, manufacturer manuals, drawings, specifications, test points, tolerances, and acceptance criteria.
  • Ability to independently identify and troubleshoot airflow, containment, HEPA filtration, mechanical, electrical, and instrumentation-related issues.
  • Ability to accurately complete certification reports, calibration certificates, test data, and controlled service documentation in accordance with customer and quality requirements.
  • Technical training or degree in metrology, instrumentation, electronics, HVAC, mechanical/electrical technology, or a related discipline preferred; equivalent military or relevant technical experience accepted.
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