Job Opportunities API

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