Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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
