Laboratory Metrology & Software Systems Supervisor

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

The 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.

Lead 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.

• Lead 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.

• Own 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.

• Support 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.

• Coordinate 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.

• Lead 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.

• Manage 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.

• Coordinate 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.

• Maintain 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.

• Provide 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.

• Support 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.

• Trend 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.

• Laboratory Calibration On-Time Compliance
• Laboratory Preventive Maintenance On-Time Compliance
• Past-Due Calibration / PM Rate
• Out-of-Tolerance and Repeat Instrument Failure Rate
• Laboratory Equipment Availability and Downtime
• Calibration / PM Turnaround Time
• OOT Investigation and CAPA Closure Timeliness
• External Service Provider Performance
• Training / Qualification Compliance
• Laboratory Software User Access Management Compliance
• Laboratory Software System Maintenance / Support Timeliness
• Laboratory Software Issue Resolution / Escalation Timeliness
• Audit and Inspection Readiness

Quality Control Analytical Development Quality Assurance Validation Software System Administrators Laboratory Systems / IT Quality Systems Procurement External Calibration and Instrument Service Providers Software Vendors / Support Providers

This role does not own or manage manufacturing equipment production process instrumentation manufacturing preventive maintenance facilities building systems utility calibration programs or manufacturing software systems. These systems remain under the appropriate Engineering Facilities Maintenance Manufacturing or IT organizations.

Education: Bachelors degree in Engineering Metrology Chemistry Life Sciences Quality or another relevant technical/scientific discipline preferred. Equivalent technical education and significant relevant experience may be considered.

Experience: Typically 5 years of experience in laboratory metrology calibration instrumentation laboratory equipment Quality laboratory software systems administration or a combination of these areas within pharmaceutical biotechnology medical device or another regulated environment with prior supervisory or technical leadership experience preferred. Experience with GMP calibration programs equipment lifecycle management user access management system maintenance and troubleshooting investigations CAPAs change control and regulatory inspections is strongly preferred.

• Laboratory Metrology & Calibration
• GMP Laboratory Equipment Lifecycle Management
• Measurement Traceability
• Out-of-Tolerance Investigations
• Laboratory Data Impact Assessment
• Root Cause Analysis & CAPA
• Quality Risk Management
• cGMP & Data Integrity
• Equipment Qualification
• Technical Problem Solving
• People Leadership & Development
• Cross-Functional Collaboration
• Metrics & Performance Management
• Laboratory Software Systems Administration
• User Access Management
• System Maintenance & Troubleshooting
• Regulatory Inspection Readiness