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 workplace. 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:

India: 01:00 PM to 10:00 PM IST

Philippines: 03:30 PM to 12:30 AM PHT

📌 Sr Applications Administrator (India)
🏢 Thermo Fisher Scientific
📍 India