About this role
Position Summary
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.
Education and Experience
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.Prior experience as a Field Service Engineer, Senior Technician, Metrology Specialist, or equivalent technical position preferred.Technical Expertise
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 devicesTemperature mapping systemsPipettesBalances and scalesOvens and furnacesIncubatorsRefrigerators and freezersEnvironmental chambersAutoclaves and sterilizersPressure and vacuum systemsFlow measurement devicesFume hoods and laboratory hoodsBiosafety cabinetsHEPA filtration systemsEnvironmental monitoring equipmentGas Chromatography (GC) systemsHigh-Performance Liquid Chromatography (HPLC) systemsUltra-Performance Liquid Chromatography (UPLC) systemsAdditional laboratory instrumentation and analytical systemsQuality and Regulatory Knowledge
Expert knowledge of ISO/IEC 17025 requirements, including:Metrological traceabilityMeasurement uncertainty analysisDecision rulesCalibration interval optimizationAccreditation complianceTraceability to NIST and other National Metrology Institutes (NMIs)Knowledge of:ISO 14644 Parts 1, 2 and 3NSF/ANSI 49Good Documentation Practices (GDP)Equipment qualification and validation requirementsExperience supporting Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.Professional Skills
Strong technical writing skills with demonstrated experience authoring:Calibration proceduresQualification protocolsValidation documentationTechnical reportsStandard Operating Procedures (SOPs)Work instructionsCustomer compliance reportsExcellent 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.CETA Certification Delivery
Expected to hold or actively pursue certification through CETAPerform and authenticate certification and requalification of cleanrooms and controlled environments, including:Airflow velocity and volume testing, unidirectional and non-unidirectionalHEPA and ULPA filter installation leak testing by aerosol photometer or discrete particle counter scanningRoom pressurization and pressure cascade verificationAirflow visualization studies, including recording and interpretationRecovery testing and containment leak testingWork with environmental monitoring technicians to carry out non-viable airborne particle countingBiosafety cabinet and fume hood certification to NSF/ANSI 49Author 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 processesTrain 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.Additional Requirements
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.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 accuratelyAdhere to environmental health and safety guidelines.Perform other tasks as assigned by Management Position is full-time, Monday through Friday, 8am-5pm with overtime as needed. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply.
Pay range: $90,000 - $130,000 annually depending on related experience and qualification
Excellent full time benefits including
Comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.