Technical Lead, Cleanroom Certification
Core
Certify and requalify cleanrooms, controlled environments, biosafety cabinets, and fume hoods to NSF/ANSI 49 standards.
Role type
Technical Lead, Cleanroom Certification
Builds
Certification reports and validated test methods for cleanroom and controlled environment services
Domain
Life sciences / Pharmaceutical manufacturing / Cleanroom engineering
Required skills
Cleanroom certification (CETA/CNBT/NEBB/AABC), ISO 14644, NSF/ANSI 49, instrument calibration, root cause analysis, technical documentation, gowned work at height
Preferred skills
USP, cGMP, state board of pharmacy requirements, biosafety cabinet field certification
Technologies
Cleanroom testing instruments, calibration tools
Responsibilities
Certify and requalify cleanrooms and controlled environments; Certify biosafety cabinets and fume hoods to NSF/ANSI 49; Author and sign certification reports; Maintain instrument set calibration and traceability; Investigate failed test results; Contribute to test methods and procedures
Seniority
Mid-level, hands-on technical lead with growth to management