Senior Field Service Engineer

Eurofins USA BioPharma Services•San Diego, CA

5d•Onsite

About The Position

The Senior Field Service Engineer (FSE) is a recognized technical authority and Subject Matter Expert (SME) in calibration, metrology, equipment qualification, preventive maintenance, troubleshooting, and repair of laboratory instrumentation, particularly with controlled environments and critical process equipment. This position serves as a senior-level technical resource responsible for developing, maintaining, and improving technical standards, calibration methodologies, qualification protocols, and Standard Operating Procedures (SOPs) that support regulatory compliance and operational excellence. The Senior FSE provides mentoring, and training to field service personnel while serving as the primary escalation point for complex technical issues. The role requires extensive expertise in metrological traceability, measurement uncertainty and regulatory compliance, ensuring equipment accuracy, reliability, and compliance across pharmaceutical, biotechnology, healthcare, medical device, manufacturing, and laboratory environments. This role will eventually hold 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. As such, the successful candidate will hold, or actively pursue, professional certifications from CETA in addition to recognized organizations such as ANSI, ASQ (Certified Calibration Technician), NSF/ANSI 49, or equivalent industry-recognized programs.

Requirements

Bachelor’s degree in Chemistry, Analytical Chemistry, Electronic Engineering, Metrology, Physics, Life Sciences, or a related technical discipline; or an equivalent combination of education, training, and relevant professional experience.
Minimum of 7-10 years of progressive experience in calibration, metrology, equipment maintenance, qualification, validation, laboratory instrumentation, or technical service environments.
Recognized Subject Matter Expert (SME) in calibration, preventive maintenance, troubleshooting, qualification, validation support, and repair of laboratory and critical process equipment, particularly with controlled environments.
Extensive experience servicing and calibrating equipment including, but not limited to: Thermometers and temperature measurement devices, Temperature mapping systems, Pipettes, Balances and scales, Ovens and furnaces, Incubators, Refrigerators and freezers, Environmental chambers, Autoclaves and sterilizers, Pressure and vacuum systems, Flow measurement devices, Fume hoods and laboratory hoods, Biosafety cabinets, HEPA filtration systems, Environmental monitoring equipment, Gas Chromatography (GC) systems, High-Performance Liquid Chromatography (HPLC) systems, Ultra-Performance Liquid Chromatography (UPLC) systems, Additional laboratory instrumentation and analytical systems.
Expert knowledge of ISO/IEC 17025 requirements, including: Metrological traceability, Measurement uncertainty analysis, Decision rules, Calibration interval optimization, Accreditation compliance, Traceability to NIST and other National Metrology Institutes (NMIs).
Knowledge of: ISO 14644 Parts 1, 2 and 3, NSF/ANSI 49, Good Documentation Practices (GDP), Equipment qualification and validation requirements.
Experience supporting Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
Strong technical writing skills with demonstrated experience authoring: Calibration procedures, Qualification protocols, Validation documentation, Technical reports, Standard Operating Procedures (SOPs), Work instructions, Customer compliance reports.
Excellent analytical, troubleshooting, and root-cause investigation skills.
Effective communicator capable of interacting with customers, regulators, auditors, management, and technical teams.
Demonstrated ability to manage multiple projects, priorities, and customer commitments with minimal supervision.
Valid driver's license with an acceptable driving record.
Ability to travel throughout assigned territories up to five days per week, including overnight travel as required.
Ability to lift, transport, install, maintain, and service equipment within laboratory, manufacturing, healthcare, biotechnology, pharmaceutical, medical device, and controlled-environment settings.

Nice To Haves

Prior experience as a Field Service Engineer, Senior Technician, Metrology Specialist, or equivalent technical position preferred.
Hold or actively pursue professional certifications from CETA in addition to recognized organizations such as ANSI, ASQ (Certified Calibration Technician), NSF/ANSI 49, or equivalent industry-recognized programs.

Responsibilities

Develop, maintain, and improve technical standards, calibration methodologies, qualification protocols, and Standard Operating Procedures (SOPs).
Provide mentoring and training to field service personnel.
Serve as the primary escalation point for complex technical issues.
Perform and authenticate certification and requalification of cleanrooms and controlled environments, including: Airflow velocity and test, HEPA and ULPA filter leak testing, Room pressurization and pressure cascade verification, Airflow visualization studies, Recovery testing and containment leak testing.
Work with environmental monitoring technicians to carry out non-viable airborne particle counting.
Perform Biosafety cabinet and fume hood certification to NSF/ANSI 49.
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.
Establish and maintain the business's CETA registration, and deliver all certification work to CETA standards.
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.
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.
Adhere to environmental health and safety guidelines.
Perform other tasks as assigned by Management.