Laboratory Metrology & Software Systems Supervisor

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Position SummaryThe Laboratory Metrology & Software Systems Supervisor leads and manages the site laboratory metrology and calibration program and provides oversight of Laboratory Software System Administrators. The role ensures GMP laboratory instruments, measuring devices, reference standards, and laboratory software systems supporting Quality Control (QC) and Analytical Development (AD) remain reliable, controlled, supported, and inspection-ready throughout their lifecycle. Reporting to the Quality & Compliance Manager, this role provides technical leadership for laboratory instrument calibration, preventive maintenance coordination, equipment lifecycle management, out-of-tolerance investigations, service-provider management, metrology documentation and compliance, as well as software user access management, system maintenance, and troubleshooting. The Supervisor partners primarily with Quality Control, Analytical Development, Quality Assurance, Validation, Laboratory Systems / IT, Procurement, and external service providers to support reliable analytical data and timely laboratory testing. Key Purpose of the RoleLead compliant and reliable Laboratory Metrology and Laboratory Software Systems support programs that keep GMP laboratory instruments supporting QC and AD calibrated, qualified, maintained, and fit for intended use while ensuring laboratory software systems are appropriately administered, maintained, and supported. Protect the integrity of analytical data, minimize laboratory downtime, support timely laboratory testing and product release activities, and maintain regulatory inspection readiness. Leadership & People DevelopmentLead, coach, develop, and provide daily direction to Laboratory Metrology personnel and Software System Administrators. Assign and prioritize work based on laboratory testing schedules, equipment criticality, and compliance requirements. Maintain training, qualification, cross-training, backup coverage, and competency requirements for Metrology personnel and Software System Administrators. Establish clear expectations for quality, compliance, productivity, responsiveness, and customer service. Laboratory Metrology Program ManagementOwn and manage the GMP laboratory metrology and calibration program. Ensure laboratory instruments are calibrated and maintained within approved intervals and prevent use of instruments with expired, failed, or unacceptable calibration status. Maintain the laboratory calibration schedule and ensure calibration procedures, tolerances, ranges, frequencies, and acceptance criteria are appropriate for intended use. Ensure calibration records and equipment histories are complete, accurate, traceable, and inspection-ready. Laboratory Instrument Lifecycle ManagementSupport laboratory instruments from introduction and asset registration through qualification, calibration, preventive maintenance, repair, change management, requalification, and retirement. Partner with QC, AD, and Validation to establish calibration and qualification requirements before GMP use. Assess instrument changes for potential impact to qualification, calibration, analytical methods, and previously generated laboratory data. Calibration & Preventive MaintenanceCoordinate laboratory instrument calibration and preventive maintenance activities to minimize disruption to laboratory testing. Monitor upcoming and overdue activities, proactively manage risks, and ensure equipment is appropriately returned to GMP service following calibration, maintenance, or repair. Review calibration certificates and service documentation for compliance, accuracy, and completeness. Out-of-Tolerance & Instrument InvestigationsLead or support investigations involving failed calibrations, out-of-tolerance conditions, and laboratory instrument performance issues. Assess potential impact to analytical data, stability results, testing, and product disposition, including the appropriate retrospective impact period. Ensure scientifically sound root cause analysis, effective CAPAs, and trending of recurring equipment or calibration failures. Escalate significant quality, compliance, data integrity, or business risks to the Quality & Compliance Manager. Calibration Standards & TraceabilityManage laboratory reference standards used for calibration and ensure standards remain current, controlled, and appropriately stored. Maintain measurement traceability to recognized national or international standards, where applicable. Ensure certificates appropriately document calibration status, traceability, and measurement results. External Service Provider ManagementCoordinate and provide technical oversight of external calibration and laboratory equipment service providers. Ensure vendors meet established technical and Quality requirements and review vendor service documentation before equipment is returned to GMP use. Monitor vendor quality, turnaround time, responsiveness, and recurring performance issues in partnership with Procurement and Quality. Laboratory Equipment GovernanceMaintain accurate laboratory equipment master data, including equipment status, calibration and preventive maintenance frequencies, criticality, qualification status, and service history. Establish routine governance with QC and AD leadership to review equipment status, upcoming and overdue activities, OOT events, instrument availability, and equipment risks. Provide clear metrics and escalation of issues that may impact laboratory testing or product release. Laboratory Software Systems AdministrationProvide leadership and daily oversight for Software System Administrators supporting GMP laboratory software systems used by QC and AD. Ensure user access management activities are performed in accordance with approved procedures and established system roles and responsibilities. Oversee routine system maintenance activities to support reliable and compliant operation of laboratory software systems. Ensure timely troubleshooting and resolution or escalation of laboratory software system issues to minimize disruption to laboratory testing. Coordinate with Laboratory Systems / IT, Quality, Validation, vendors, and system owners as needed to support system maintenance and issue resolution. Quality Systems & ComplianceSupport deviations, investigations, CAPAs, change controls, and Quality Risk Management activities related to laboratory instruments and laboratory software systems. Ensure compliance with applicable cGMP requirements, approved procedures, and ALCOA+ data integrity principles for laboratory instruments and laboratory software systems. Maintain inspection readiness and serve as a subject matter leader for Laboratory Metrology and Laboratory Software Systems administration during internal, client, and regulatory inspections. Continuous ImprovementTrend laboratory equipment performance and identify opportunities to improve reliability and reduce downtime. Optimize calibration and preventive maintenance frequencies using documented science- and risk-based approaches. Standardize metrology and laboratory software administration procedures, tools, documentation, and digital solutions for scheduling, records, dashboards, access management, maintenance, troubleshooting, and lifecycle management. Key Performance IndicatorsLaboratory