Sr Applications Administrator

Work Schedule

Environmental Conditions

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

• Bachelors 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