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
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Administer and support LIS, Instrument Manager (or similar middleware), and laboratory interfaces.
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Configure instrument interfaces, test mappings, routing rules, and communication protocols (TCP/IP, serial, file-based).
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Execute Computer System Validation (IQ/OQ/PQ), validation documentation, and objective evidence.
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Perform End-to-End (E2E) testing and verify data integrity across instruments, middleware, and LIS.
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Manage change controls, impact assessments, system upgrades, and production deployments.
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Troubleshoot interface, mapping, and data transmission issues.
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Maintain audit-ready documentation and ensure compliance with GxP, 21 CFR Part 11, GDP, and ALCOA+.
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Collaborate with Laboratory Operations, QA, Validation, and IT teams.
Required Qualifications
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Bachelor's degree in IT, Computer Science, Engineering, Medical Technology, Clinical Laboratory Science, or related field.
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5+ years supporting laboratory or regulated healthcare applications.
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3+ years administering LIS, laboratory middleware, or medical device interfaces.
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Experience with GxP, CSV (IQ/OQ/PQ), change control, validation, and audit support.
Required Skills
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Laboratory Information Systems (LIS)
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Instrument Manager (or equivalent middleware)
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Medical device/instrument interfaces
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Computer System Validation (IQ/OQ/PQ)
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End-to-End Testing & Data Integrity
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Test mapping and configuration management
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Interface troubleshooting
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Change Control & Validation Documentation
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TCP/IP, serial communication
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Audit-ready documentation
Preferred Skills
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HL7/ASTM messaging
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GAMP 5
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Clinical laboratory or pharmaceutical domain experience
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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
