Senior Field Service Engineer

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 businesss 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 firms 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. 

Qualifications :

Education and Experience

• Bachelors 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 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

Quality and Regulatory Knowledge

• 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.

Professional Skills

• 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.

CETA Certification Delivery

• Expected to hold or actively pursue certification through CETA
• 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
  • Work with environmental monitoring technicians to carry out non-viable airborne particle counting
  • 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 including technicians outside of the direct reporting line.
• Establish and maintain the businesss 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 drivers 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 accurately
• Adhere to environmental health and safety guidelines.
• Perform other tasks as assigned by Management

Additional Information :

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: $90000 - $130000 annually depending on related experience and qualification

Excellent full time benefits including

• Comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time