13 Aug
|
Thermo Fisher Scientific
|
Bengaluru
13 Aug
Thermo Fisher Scientific
Bengaluru
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
SUMMARY
The Senior Application Administrator is responsible for the administration, configuration, validation, and lifecycle management of laboratory middleware and instrument interfaces within a regulated GxP setting. This role serves as the technical owner for instrument-to-LIS integrations, ensuring compliance with 21 CFR Part 11, Good Documentation Practices (GDP), Computer System Validation (CSV) requirements, and company quality standards.
The position partners closely with Laboratory Operations, Quality Assurance, Validation, and Information Technology teams to implement, validate, maintain, and support medical device interfaces and associated workflows. Responsibilities include change control execution, configuration management, IQ/OQ/PQ activities, end-to-end testing, data integrity verification, audit support, and production support of laboratory applications.
ESSENTIAL RESPONSIBILITIES
Application Administration & Interface Management - Administer and support laboratory middleware applications, including Instrument Manager and associated laboratory information systems (LIS). - Configure and maintain instrument interfaces, routing rules, test mappings, code mappings, and communication parameters. - Manage application configurations across Development, Test, Validation, and Production environments. - Support onboarding of new instruments, analyzers, assays, and third-party laboratory interfaces. - Configure and maintain TCP/IP, serial, file-based, and other interface communication methods. - Perform troubleshooting and root cause analysis for interface failures, transmission issues, mapping discrepancies, and data integrity concerns.
Computer System Validation (CSV) - Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities. - Author, review, and execute validation protocols, test scripts, valid
📌 Sr Applications Administrator (Bengaluru)
🏢 Thermo Fisher Scientific
📍 Bengaluru