Job Overview
This senior-level engineering role supports validation, calibration, and analytical technology functions across diverse life science environments. The position requires deep chromatography expertise and the ability to lead technical operations in regulated settings. Candidates who bring advanced problem-solving skills, strong regulatory knowledge, and hands-on proficiency with laboratory instrumentation will be prioritized for interview.
Must Haves
- Bachelor’s degree in an engineering or scientific discipline
- 7+ years working with laboratory equipment in regulated environments (ISO 17025 and GxP)
- 5+ years of direct calibration, validation, and metrology experience
- Extensive technical experience with chromatography platforms (e.g., LC, LC/MS, GC, GC/MS, IC, SFC)
- Demonstrated ability to develop and execute IQ/OQ/PQ protocols
- Strong understanding of ISO 17025, ANSI/NCSL Z540, and FDA/EMA expectations
- Proven analytical troubleshooting skills with experience resolving complex equipment issues
- Skilled in mentoring technical teams and communicating with external stakeholders
What the Client Needs You to Do
This role supports critical laboratory and manufacturing operations by ensuring calibrated, validated, and compliant instrumentation. You will address complex technical challenges, guide staff on best practices, strengthen service processes, and serve as a key escalation point for chromatography systems. Collaboration across quality, research, and service teams will be essential to uphold accuracy, improve efficiency, and support ongoing accreditation.
Key Responsibilities
- Lead implementation and continuous improvement of quality processes aligned with ISO 17025 requirements
- Develop calibration schedules, confirm metrological traceability, and maintain uncertainty documentation
- Design, author, and execute validation protocols for equipment, methods, and processes
- Maintain detailed calibration and validation records to support audits and regulatory reviews
- Perform planned maintenance, repairs, and verification on multi-vendor laboratory instruments
- Train and mentor staff on calibration techniques, compliance expectations, and validation standards
- Act as subject matter expert for chromatography systems, offering advanced troubleshooting and guidance
- Conduct qualification activities for chromatography equipment in alignment with regulatory standards
- Develop SOPs for qualification processes and generate supporting reports
- Support service models, labor planning, and materials forecasting to strengthen operational performance
- Deliver on-site and remote service, including installations, maintenance, and technical support
- Guide engineering colleagues on chromatography-specific maintenance and repair
- Communicate directly with customers to resolve escalated issues and ensure high-quality service outcomes
- Partner with cross-functional teams to resolve technical challenges and integrate new products or services
- Participate in internal and external audits to maintain compliance and accreditation
- Drive continuous improvements in workflows, pricing structures, and training programs
Additional Information
- Work may occur in laboratory, manufacturing, or controlled environmental spaces
- Some travel may be required for field service assignments
- Role may involve hybrid on-site and remote support, depending on client needs
- Must be able to lift or carry up to 50 pounds routinely
- Position requires full adherence to workplace safety practices, including OSHA-aligned protocols for biohazards, sharps, chemicals, temperature exposure, and equipment operation
- Sensory and motor requirements include distinguishing temperature ranges, color differentiation, fine motor use, and manual dexterity
- Completion of all required safety training is mandatory
W2 employees of Overture Partners who work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), 401(k) starting on day one, a variety of voluntary benefits including life and disability insurance, and sick time if required by law in the worked-in state/locality.
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