**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
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Required Skill Profession

Other General

📌 Sr Applications Administrator (Bengaluru)
🏢 ThermoFisher Scientific
📍 Bengaluru