The Senior FSE is considered a subject matter expert in the field of Calibrations, Preventative Maintenance and Repairs and the technical authority for the calibration and certification of clean rooms, biosafety cabinets and other controlled environments. They are expected to be CETA certified, write protocols, methods and SOP’s within their field of expertise, train and direct calibrations, qualifications, and certifications, and review and approve certification work carried out by other field service personnel.
The role holds the professional credential on which the business's certification registration depends. The business will operate initially under CETA registration, and the role is accountable for building the operating record, testing hours and customer endorsements required to obtain NEBB Cleanroom Performance Testing firm certification, and for holding the NEBB certification personally on the firm's behalf.
Certification Delivery
- Perform and authenticate certification and requalification of cleanrooms and controlled environments, including:
- Airflow velocity and volume testing, unidirectional and non-unidirectional
- HEPA and ULPA filter installation leak testing by aerosol photometer or discrete particle counter scanning
- Room pressurization and pressure cascade verification
- Airflow visualization studies, including recording and interpretation
- Recovery testing and containment leak testing
- Non-viable airborne particle counting and ISO classification, including sample location determination
- Biosafety cabinet and fume hood certification to NSF/ANSI 49
- Isolator, RABS and glovebox testing, including glove integrity
- Author test methods, certification protocols and standard operating procedures for the service line, and maintain them through revision.
- Review and approve certification reports produced by other engineers and technicians.
- Investigate out-of-specification results and support customer deviation and corrective action processes
- Train and direct field service personnel carrying out clean room certifications, including technicians outside of the direct reporting line.
- Establish and maintain the business's CETA registration, and deliver all certification work to CETA standards from appointment.
- Build the record required for NEBB CPT firm certification — continuous operating history, annual cleanroom testing hours, instrument ownership, local chapter membership and endorsement letters — and manage the application.
- Obtain NEBB CPT certification personally, completing the Technician examinations and subsequently the Certified Professional examinations, so that the business can authenticate NEBB Certified Reports.
- Maintain relationships with customers and awarding authorities who may provide endorsement in support of firm certification.
- Support the evaluation and, if pursued, the technical scope of ISO 17025 accreditation for physical certification.
Team
- Establish the training and qualification pathway for certification engineers and technicians within and outside the direct reporting line.
- Train, mentor and assess engineers and technicians toward CETA and NEBB certification, and sign their competency records.
Instruments
- Specify, commission and maintain the certification instrument set, including particle counters, aerosol photometers and generators, balometers and flow hoods, thermal and vane anemometers, and micromanometers. Assist in the calibration of similar equipment used by other Eurofins businesses.
- Perform troubleshooting, preventative maintenance and repair both in the field and in the lab of various types of laboratory equipment including balances, pH meters, environmental monitoring equipment, hoods, biosafety cabinets, room HEPA filters, plate readers and chambers.
- Manage personal parts inventory effectively.
- Provide feedback to Director regarding any issue impacting service delivery, particularly issues impacting turnaround times.
Commercial and administrative
- Provide the technical basis for quotations, including room counts, classification, test scope and frequency.
- Represent the business technically to customers during scoping discussions and audits.
- Complete administrative paperwork and reports promptly and accurately.
- Follow good documentation practices (GDP) as applicable to daily activities.
- Contact customers on time and schedule service efficiently.
- Adhere to environmental health and safety guidelines.
- Effectively communicate with clients and other internal and external parties.
- Follow Eurofins work policies and all applicable SOPs. Ensure that training on both remains current.
- Maintain client confidentiality, specifically if information about the customer is obtained from sources other than the customer (e.g. complainant, assessors).
- Act impartially within the management system.
- Perform other tasks as assigned by Management.