Senior IT Applications Administrator
Thermo Fisher Scientific
Summary
The Senior Application Administrator is responsible for administering, configuring, validating, and supporting laboratory middleware, LIS applications, and instrument interfaces within a regulated GxP environment. This role ensures reliable instrument-to-LIS integrations, data integrity, regulatory compliance, and appropriate system lifecycle documentation. The position works closely with Laboratory Operations, Quality Assurance, Validation, and IT teams.
Job description
Purpose
- Administer and support laboratory middleware, LIS applications, and instrument interfaces.
- Configure instrument connections, test/code mappings, routing rules, communication parameters, and application settings.
- Support onboarding and implementation of new instruments, analyzers, assays, and laboratory interfaces.
- Manage configurations across Development, Test, Validation, and Production environments.
- Troubleshoot interface, connectivity, mapping, transmission, and data integrity issues.
- Execute Computer System Validation (CSV) activities, including IQ, OQ, and PQ.
- Develop and execute validation protocols, test scripts, traceability documentation, and validation evidence.
- Perform end-to-end testing from instrument processing through middleware and LIS reporting.
- Review logs, audit trails, interface transactions, and reports to verify data integrity.
- Support change controls, risk assessments, system upgrades, configuration changes, and production deployments.
- Maintain compliance with 21 CFR Part 11, GxP, GDP, ALCOA+, and company quality procedures.
- Maintain audit-ready documentation and support internal and regulatory inspections.
- Collaborate with Laboratory Operations, QA, Validation, and IT teams and provide technical guidance to junior administrators.
Education and Experience
- Bachelor's degree in IT, Computer Science, Engineering, Clinical Laboratory Science, Medical Technology, or a related field; equivalent experience may be considered.
- 5+ years of experience supporting regulated laboratory, healthcare, clinical, or manufacturing applications.
- 3+ years of experience with laboratory instruments, middleware, LIS, or medical device integrations.
- Experience with GxP environments, CSV, IQ/OQ/PQ, change control, validation documentation, and audit support.
- Knowledge of TCP/IP, serial communications, interface troubleshooting, and configuration management.
Preferred Qualifications
- Experience with Instrument Manager or comparable laboratory middleware.
- Knowledge of HL7, ASTM, GAMP 5, laboratory workflows, and quality control systems.
- Experience with audit trails, data integrity assessments, assay validation, and reportable ranges.
- Experience in clinical laboratories, pharmaceutical, biotechnology, CRO, or medical device environments.
Regulatory Knowledge
21 CFR Part 11 • GxP • GCP • GLP • GDP • CSV • ALCOA+ • Change Control • CAPA • Deviation Management
Key Competencies
Validation & Compliance • Data Integrity • Technical Troubleshooting • Root Cause Analysis • Documentation • Cross-Functional Collaboration • Project Coordination • Audit Readiness
Requirements
- Bachelor's degree in IT, Computer Science, Engineering, Clinical Laboratory Science, Medical Technology, or a related field; equivalent experience may be considered.
- 5+ years of experience supporting regulated laboratory, healthcare, clinical, or manufacturing applications.
- 3+ years of experience with laboratory instruments, middleware, LIS, or medical device integrations.
- Experience with GxP environments, CSV, IQ/OQ/PQ, change control, validation documentation, and audit support.
- Knowledge of TCP/IP, serial communications, interface troubleshooting, and configuration management.
- Must be legally authorized to work in the United States without sponsorship.
- Must be able to pass a comprehensive background check, which includes a drug screening (where applicable).
- Greater Cincinnati/Northern KY location required, Relocation assistance is not provided.
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.