Sr Applications Administrator (Laboratory Systems & Medical Device Interfaces)

ThermoFisher Scientific; Taguig; On-site; PHP 1,200,000 - 2,000,000; Full time

Job summary

Thermo Fisher Scientific in Taguig, Philippines, seeks a Senior Application Administrator to manage LIS, middleware, and lab interfaces within a GxP-regulated environment. You will validate systems, ensure data integrity, and support instrument integrations through CSV and change control.

The role collaborates with QA, Validation, IT, and Laboratory Operations to maintain audit-ready documentation and comply with 21 CFR Part 11, GDP, ALCOA+.

Qualifications

• Bachelor's degree in IT, CS, 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.

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.

Skills

LIS

Instrument Manager

Medical device interfaces

Computer System Validation (IQ/OQ/PQ)

End-to-End Testing

Data Integrity

Test mapping

Configuration management

Interface troubleshooting

Change Control

TCP/IP

Audit-ready documentation

Education

Bachelor's degree in IT, CS, Engineering, Medical Technology, Clinical Laboratory Science, or related field

Tools

Instrument Manager

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

• 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:

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.