Technical Lead, Cleanroom Certification

Eurofins USA BioPharma Services•Boston, PA

About The Position

This is a hands-on role with growth potential to train and lead technical staff, intended for a working certifier seeking increased responsibility. The role certifies and requalifies cleanrooms and controlled environments, certifies biosafety cabinets and fume hoods to NSF/ANSI 49, authors and signs certification reports, maintains calibration and traceability of the instrument set, investigates failed results and helps customers identify causes, and contributes to service-line test methods and procedures. There is potential to progress into a managerial role.

Requirements

  • Hold a current certification credential in good standing, such as CETA/CNBT RCP-CT, CETA/CNBT RCP-SCF, NEBB Cleanroom Performance Testing, or AABC; alternatively, have two or more years of hands-on cleanroom certification experience and willingness and technical readiness to take the exams.
  • Working knowledge of ISO 14644 and NSF/ANSI 49.
  • Careful and accurate documentation habits.
  • Sound independent judgment.
  • High school diploma or equivalent.
  • Valid driver's license and a clean driving record.
  • Able to lift and position test equipment, work at height at filter housings, and remain gowned for long periods.

Nice To Haves

  • Familiarity with USP <797> and <800>, cGMP, or state board of pharmacy requirements.
  • Optional NSF/ANSI 49 accredited biosafety cabinet field certifier credential.
  • A technical certification or a degree in a related field is welcome but not required.

Responsibilities

  • Certify and requalify cleanrooms and controlled environments.
  • Certify biosafety cabinets and fume hoods to NSF/ANSI 49.
  • Author and sign certification reports.
  • Own the instrument set and keep it calibrated and traceable.
  • Investigate failed results and help customers determine why they failed.
  • Contribute to test methods and procedures for the service line.
  • Train and lead technical staff as the role develops.

Benefits

  • Comprehensive medical coverage
  • Dental options
  • Vision options
  • Life insurance
  • Disability insurance
  • 401(k) with company match
  • Paid vacation
  • Paid holidays
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