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