Germer International
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.)
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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.)
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