Technical Lead, Cleanroom Certification

Eurofins USA BioPharma Services•Raleigh, PA

About The Position

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

Requirements

  • Hold a current certification credential in good standing: CETA/CNBT Registered Certification Professional – Cleanroom Testing (RCP-CT), CETA/CNBT Registered Certification Professional – Sterile Compounding Facilities (RCP-SCF), or NEBB Cleanroom Performance Testing; alternatively, have two or more years of hands-on cleanroom certification experience and be willing and technically ready 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.
  • Ability 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.
  • Technical certification or a degree in a related field.
  • NSF/ANSI 49 accredited biosafety cabinet field certifier certification.

Responsibilities

  • Certify and requalify cleanrooms and controlled environments.
  • Certify biosafety cabinets and fume hoods to NSF/ANSI 49.
  • Author and sign certification reports.
  • Maintain the instrument set and ensure its calibration and traceability.
  • Investigate failed results and help customers determine the cause.
  • Contribute to test methods and procedures for the service line.
  • Train and lead technical staff as the role develops.

Benefits

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