Sr Applications Administrator (Laboratory Systems & Medical Device Interfaces)

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