Equipment Engineer III (ISO 17025)

Germer International; Boston (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

A leading life sciences company based in Boston is seeking a Life Science Engineer III to oversee calibration and validation processes in compliance with GxP and ISO standards. This role requires extensive experience in chromatography systems and involves mentoring staff and ensuring service excellence. The ideal candidate has at least 7 years of relevant experience, a Bachelor's degree in a scientific field, and the ability to collaborate cross-functionally to enhance operational efficiency and customer satisfaction.

Qualifications

• 7+ years of experience with life science laboratory equipment in regulated environments.
• 5+ years of direct experience in validation, calibration, and metrology.
• 7+ years of technical experience with chromatography systems.

Responsibilities

• Oversee calibration and validation processes in GxP and ISO 17025 environments.
• Lead implementation of Quality Management System in alignment with ISO 17025.
• Act as SME for chromatography and analytical systems.

Skills

Calibration and validation expertise

Chromatography systems knowledge

Quality Management System (QMS)

Regulatory compliance

Education

Bachelor’s degree in Engineering, Chemistry, Biochemistry, Physics, or related scientific discipline

Tools

Laboratory instruments (balances, centrifuges, PCRs, etc.)

Chromatography equipment (LC, GC, etc.)

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 reportsSupport 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.)