Sr Applications Administrator (Laboratory Systems & Medical Device Interfaces)

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Senior Application Administrator (Laboratory Systems & Medical Device Interfaces) Job Summary The 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 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. Required Qualifications Bachelor'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 Skills Laboratory Information Systems (LIS) Instrument Manager (or equivalent middleware) Medical device/instrument interfaces Computer System Validation (IQ/OQ/PQ) End-to-End Testing & Data Integrity Test mapping and configuration management Interface troubleshooting Change Control & Validation Documentation TCP/IP, serial communication Audit-ready documentation Preferred Skills HL7/ASTM messaging GAMP 5 Clinical laboratory or pharmaceutical domain experience Laboratory workflow, QC, and assay validation knowledge Compliance Knowledge 21 CFR Part 11 • GxP • GLP • GCP • GDP • CSV • ALCOA+ • CAPA • Change Control Key Competencies Mandatory: 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