Senior Applications Administrator

**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