Sr Applications Administrator (Laboratory Systems & Medical Device Interfaces)
Thermo Fisher Scientific
Sr Applications Administrator (Laboratory Systems & Medical Device Interfaces)
Job Description
Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionSenior Application Administrator (Laboratory Systems & Medical Device Interfaces)Job SummaryThe Senior Application Administrator is responsible for administering, configuring, validating, and supporting Laboratory Information Systems (LIS), laboratory middleware, and medical device interfaces in a GxP-regulated environment. The role ensures compliant, reliable instrument integrations through Computer System Validation (CSV), data integrity, change control, and production support.Key ResponsibilitiesAdminister and support LIS, Instrument Manager (or similar middleware), and laboratory interfaces.Configure instrument interfaces, test mappings, routing rules, and communication protocols (TCP/IP, serial, file-based).Execute Computer System Validation (IQ/OQ/PQ), validation documentation, and objective evidence.Perform End-to-End (E2E) testing and verify data integrity across instruments, middleware, and LIS.Manage change controls, impact assessments, system upgrades, and production deployments.Troubleshoot interface, mapping, and data transmission issues.Maintain audit-ready documentation and ensure compliance with GxP, 21 CFR Part 11, GDP, and ALCOA+.Collaborate with Laboratory Operations, QA, Validation, and IT teams.Required QualificationsBachelor's degree in IT, Computer Science, Engineering, Medical Technology, Clinical Laboratory Science, or related field.5+ years supporting laboratory or regulated healthcare applications.3+ years administering LIS, laboratory middleware, or medical device interfaces.Experience with GxP, CSV (IQ/OQ/PQ), change control, validation, and audit support.Required SkillsLaboratory Information Systems (LIS)Instrument Manager (or equivalent middleware)Medical device/instrument interfacesComputer System Validation (IQ/OQ/PQ)End-to-End Testing & Data IntegrityTest mapping and configuration managementInterface troubleshootingChange Control & Validation DocumentationTCP/IP, serial communicationAudit-ready documentationPreferred SkillsHL7/ASTM messagingGAMP 5Clinical laboratory or pharmaceutical domain experienceLaboratory workflow, QC, and assay validation knowledgeCompliance Knowledge21 CFR Part 11 • GxP • GLP • GCP • GDP • CSV • ALCOA+ • CAPA • Change ControlKey CompetenciesMandatory: IQ/OQ/PQ, E2E Testing, Data Integrity, Change Control, Objective Evidence.Preferred: Test Mapping, Configuration Management, Interface Troubleshooting, Laboratory Workflow, Documentation Compliance, HL7, Instrument Manager, GAMP 5.Working Hours: Philippines: 03:30 PM to 12:30 AM PHT
Locations
- Philippines, Taguig City
Skills Required
- GxPintermediate
Required Qualifications
- Bachelor's degree in IT, Computer Science, Engineering, Medical Technology, Clinical Laboratory Science, or related field. (degree in it)
- 5+ years supporting laboratory or regulated healthcare applications. (experience, 5 years)
- 3+ years administering LIS, laboratory middleware, or medical device interfaces. (experience, 3 years)
- Experience with GxP, CSV (IQ/OQ/PQ), change control, validation, and audit support. (experience)
- Bachelor's degree in IT, Computer Science, Engineering, Medical Technology, Clinical Laboratory Science, or related field. (degree in it)
- 5+ years supporting laboratory or regulated healthcare applications. (experience, 5 years)
- 3+ years administering LIS, laboratory middleware, or medical device interfaces. (experience, 3 years)
- Experience with GxP, CSV (IQ/OQ/PQ), change control, validation, and audit support. (experience)
- Laboratory Information Systems (LIS) (experience)
- Instrument Manager (or equivalent middleware) (experience)
- Medical device/instrument interfaces (experience)
- Computer System Validation (IQ/OQ/PQ) (experience)
- End-to-End Testing & Data Integrity (experience)
- Test mapping and configuration management (experience)
- Interface troubleshooting (experience)
- Change Control & Validation Documentation (experience)
- TCP/IP, serial communication (experience)
- Audit-ready documentation (experience)
- Laboratory Information Systems (LIS) (experience)
- Instrument Manager (or equivalent middleware) (experience)
- Medical device/instrument interfaces (experience)
- Computer System Validation (IQ/OQ/PQ) (experience)
- End-to-End Testing & Data Integrity (experience)
- Test mapping and configuration management (experience)
- Interface troubleshooting (experience)
- Change Control & Validation Documentation (experience)
- TCP/IP, serial communication (experience)
- Audit-ready documentation (experience)
Preferred Qualifications
- HL7/ASTM messaging (experience)
- GAMP 5 (experience)
- Clinical laboratory or pharmaceutical domain experience (experience)
- Laboratory workflow, QC, and assay validation knowledge (experience)
- HL7/ASTM messaging (experience)
- Clinical laboratory or pharmaceutical domain experience (experience)
- Laboratory workflow, QC, and assay validation knowledge (experience)
Responsibilities
- Administer and support LIS, Instrument Manager (or similar middleware), and laboratory interfaces.
- Configure instrument interfaces, test mappings, routing rules, and communication protocols (TCP/IP, serial, file-based).
- Execute Computer System Validation (IQ/OQ/PQ), validation documentation, and objective evidence.
- Perform End-to-End (E2E) testing and verify data integrity across instruments, middleware, and LIS.
- Manage change controls, impact assessments, system upgrades, and production deployments.
- Troubleshoot interface, mapping, and data transmission issues.
- Maintain audit-ready documentation and ensure compliance with GxP, 21 CFR Part 11, GDP, and ALCOA+.
- Collaborate with Laboratory Operations, QA, Validation, and IT teams.
- Administer and support LIS, Instrument Manager (or similar middleware), and laboratory interfaces.
- Configure instrument interfaces, test mappings, routing rules, and communication protocols (TCP/IP, serial, file-based).
- Execute Computer System Validation (IQ/OQ/PQ), validation documentation, and objective evidence.
- Perform End-to-End (E2E) testing and verify data integrity across instruments, middleware, and LIS.
- Manage change controls, impact assessments, system upgrades, and production deployments.
- Troubleshoot interface, mapping, and data transmission issues.
- Maintain audit-ready documentation and ensure compliance with GxP, 21 CFR Part 11, GDP, and ALCOA+.
- Collaborate with Laboratory Operations, QA, Validation, and IT teams.
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