Equipment Engineer III

Job Description

The Life Science Engineer III – Validation/Calibration & Chromatography SME will oversee calibration and validation processes in GxP and ISO 17025 environments while also serving as a technical escalation point for chromatography systems, including GC, IC, SFC, LC, and LC/MS/MS. This role ensures compliance with international standards, drives service excellence, develops staff expertise, and partners cross-functionally to enhance service delivery, operational efficiency, and customer satisfaction.

Validation & Calibration Responsibilities

• Lead the implementation and continuous improvement of the Quality Management System (QMS) in alignment with ISO 17025
• Develop and execute calibration schedules, establish metrological traceability, and document results with expanded uncertainty reporting
• Design, author, and execute validation protocols (IQ/OQ/PQ) for new or modified equipment, processes, and test methods
• Maintain accurate validation and calibration records to support audits and ISO accreditation
• Perform planned maintenance, repair, and verification services across multi-vendor laboratory instruments (balances, centrifuges, freezers, PCRs, incubators, humidity chambers, microscopes, liquid handlers, DNA analyzers, etc.)
• Train and mentor staff on calibration procedures, ISO 17025 compliance, and validation best practices

Chromatography & Service Operations Responsibilities

• Act as SME for chromatography and analytical systems (LC, GC, IC, SFC, LC/MS, GC/MS, and related platforms)
• Provide advanced troubleshooting and serve as the final point of escalation for service events in the field
• Validate and qualify chromatography equipment, ensuring compliance with FDA, EMA, and other regulatory requirements
• Develop and implement SOPs for equipment qualification and generate qualification reports
• Support service pricing structures, labor hour models, and materials planning to optimize operations
• Perform on-site and remote service support, planned maintenance, and hardware/software installations
• Coach and mentor engineering colleagues on chromatography maintenance and repair
• Communicate directly with customers to ensure service quality, provide preventive maintenance guidance, and resolve escalated issues

Cross-Functional & Continuous Improvement

• Collaborate with Quality, R&D, and Service teams to resolve technical issues and support new product/service integration
• Participate in internal and external audits to maintain accreditation and regulatory compliance
• Drive continuous improvement initiatives in service workflows, pricing, and training

Required Education & Experience

• Bachelor’s degree in Engineering, Chemistry, Biochemistry, Physics, or related scientific discipline
• 7+ years of experience with life science laboratory equipment in regulated environments (ISO 17025 and GxP)
• 5+ years of direct experience in validation, calibration, and metrology
• 7+ years of technical experience with chromatography systems (LC, LC/MS, GC, GC/MS, IC, SFC, etc.)