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Thermo Fisher Scientific
Sr Applications Administrator (Laboratory Systems & Medical Device Interfaces)Thermo Fisher Scientific • Taguig, Manila, Philippines
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Sr Applications Administrator (Laboratory Systems & Medical Device Interfaces)

Sr Applications Administrator (Laboratory Systems & Medical Device Interfaces)

Thermo Fisher Scientific • Taguig, Manila, Philippines
14 hours ago
Job description

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

  • 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:

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


Required Experience:

Senior IC


Employment Type : Full-Time
Experience: years
Vacancy: 1

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Sr Applications Administrator (Laboratory Systems & Medical Device Interfaces) • Taguig, Manila, Philippines