Ingenics
Cleanroom HEPA & GMP Compliance Expert
We are seeking a qualified and detail?oriented technician to perform the certification and routine testing of HEPA filters in cleanroom environments. The technician will ensure compliance with GMP, ISO 14644, and FDA regulatory standards by conducting filter integrity testing, airflow measurement, and environmental diagnostics. Key Responsibilities Perform
certification and integrity testing of HEPA filters
using industry?standard methods (e.g.,
PAO/Aerosol Photometer testing ). Conduct
airflow velocity and volume measurements
at terminal HEPA filters and cleanroom diffusers. Ensure compliance with
ISO 14644?1 classifications
and internal quality and safety standards. Execute
smoke visualization
studies for airflow pattern verification. Maintain detailed documentation of all testing, calibrations, and certifications per
GMP
and
SOP
requirements. Assist with troubleshooting and resolving HEPA system or cleanroom airflow issues. Coordinate with Facilities, QA, and Cleanroom Operations to schedule and execute testing activities without disrupting manufacturing. Support
cleanroom requalification , equipment commissioning, and periodic validation activities. Ensure all test equipment is maintained and calibrated in accordance with internal standards.
Qualifications
Associate's or Bachelors degree in Engineering, HVAC, Life Sciences, or a related technical field (or equivalent work experience). Minimum 23 years of experience in
cleanroom validation, HEPA filter testing, or pharmaceutical environmental monitoring . Familiarity with: ISO 14644?1 and 3 ,
IEST?RP?CC001 ,
FDA cGMP , and
Annex 1 Aerosol photometers, particle counters, anemometers, and smoke generators Strong knowledge of cleanroom classifications and airflow dynamics. Attention to detail and ability to work in regulated environments (GMP/GLP). Good interpersonal and communication skills; ability to work cross?functionally.
Preferred Qualifications
Certified Testing Technician (e.g.,
NEBB CPT ,
CETA
certification, or equivalent) Experience working in ISO 58 cleanrooms Prior experience in the pharmaceutical or biotech industry
Working Conditions
Work performed in classified cleanroom environments and mechanical spaces Must wear appropriate
gowning/PPE
per cleanroom protocol Some lifting and working on ladders or scaffolding may be required Occasional off?shift or weekend work to support production schedules
Seniority level
Associate Employment type
Full?time Job function
Other, Engineering, and Quality Assurance Industries
Business Consulting and Services and Pharmaceutical Manufacturing Location
Indianapolis, IN Salary
$59,951.00 - $93,541.00 Posting date
3 days ago #J-18808-Ljbffr
We are seeking a qualified and detail?oriented technician to perform the certification and routine testing of HEPA filters in cleanroom environments. The technician will ensure compliance with GMP, ISO 14644, and FDA regulatory standards by conducting filter integrity testing, airflow measurement, and environmental diagnostics. Key Responsibilities Perform
certification and integrity testing of HEPA filters
using industry?standard methods (e.g.,
PAO/Aerosol Photometer testing ). Conduct
airflow velocity and volume measurements
at terminal HEPA filters and cleanroom diffusers. Ensure compliance with
ISO 14644?1 classifications
and internal quality and safety standards. Execute
smoke visualization
studies for airflow pattern verification. Maintain detailed documentation of all testing, calibrations, and certifications per
GMP
and
SOP
requirements. Assist with troubleshooting and resolving HEPA system or cleanroom airflow issues. Coordinate with Facilities, QA, and Cleanroom Operations to schedule and execute testing activities without disrupting manufacturing. Support
cleanroom requalification , equipment commissioning, and periodic validation activities. Ensure all test equipment is maintained and calibrated in accordance with internal standards.
Qualifications
Associate's or Bachelors degree in Engineering, HVAC, Life Sciences, or a related technical field (or equivalent work experience). Minimum 23 years of experience in
cleanroom validation, HEPA filter testing, or pharmaceutical environmental monitoring . Familiarity with: ISO 14644?1 and 3 ,
IEST?RP?CC001 ,
FDA cGMP , and
Annex 1 Aerosol photometers, particle counters, anemometers, and smoke generators Strong knowledge of cleanroom classifications and airflow dynamics. Attention to detail and ability to work in regulated environments (GMP/GLP). Good interpersonal and communication skills; ability to work cross?functionally.
Preferred Qualifications
Certified Testing Technician (e.g.,
NEBB CPT ,
CETA
certification, or equivalent) Experience working in ISO 58 cleanrooms Prior experience in the pharmaceutical or biotech industry
Working Conditions
Work performed in classified cleanroom environments and mechanical spaces Must wear appropriate
gowning/PPE
per cleanroom protocol Some lifting and working on ladders or scaffolding may be required Occasional off?shift or weekend work to support production schedules
Seniority level
Associate Employment type
Full?time Job function
Other, Engineering, and Quality Assurance Industries
Business Consulting and Services and Pharmaceutical Manufacturing Location
Indianapolis, IN Salary
$59,951.00 - $93,541.00 Posting date
3 days ago #J-18808-Ljbffr