Senior IT Applications Administrator

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

The Senior Application Administrator is responsible for administering, configuring, validating, and supporting laboratory middleware, LIS applications, and instrument interfaces within a regulated GxP environment. This role ensures reliable instrument-to-LIS integrations, data integrity, regulatory compliance, and appropriate system lifecycle documentation. The position works closely with Laboratory Operations, Quality Assurance, Validation, and IT teams.

*Must be legally authorized to work in the United States without sponsorship.

*Must be able to pass a comprehensive background check, which includes a drug screening(where applicable)

*Greater Cincinnati/Northern KY location required, Relocation assistance is not provided.

Purpose:

• Administer and support laboratory middleware, LIS applications, and instrument interfaces.
• Configure instrument connections, test/code mappings, routing rules, communication parameters, and application settings.
• Support onboarding and implementation of new instruments, analyzers, assays, and laboratory interfaces.
• Manage configurations across Development, Test, Validation, and Production environments.
• Troubleshoot interface, connectivity, mapping, transmission, and data integrity issues.
• Execute Computer System Validation (CSV) activities, including IQ, OQ, and PQ.
• Develop and execute validation protocols, test scripts, traceability documentation, and validation evidence.
• Perform end-to-end testing from instrument processing through middleware and LIS reporting.
• Review logs, audit trails, interface transactions, and reports to verify data integrity.
• Support change controls, risk assessments, system upgrades, configuration changes, and production deployments.
• Maintain compliance with 21 CFR Part 11, GxP, GDP, ALCOA+, and company quality procedures.
• Maintain audit-ready documentation and support internal and regulatory inspections.
• Collaborate with Laboratory Operations, QA, Validation, and IT teams and provide technical guidance to junior administrators.

Education and Experience:

• Bachelor's degree in IT, Computer Science, Engineering, Clinical Laboratory Science, Medical Technology, or a related field; equivalent experience may be considered.
• 5+ years of experience supporting regulated laboratory, healthcare, clinical, or manufacturing applications.
• 3+ years of experience with laboratory instruments, middleware, LIS, or medical device integrations.
• Experience with GxP environments, CSV, IQ/OQ/PQ, change control, validation documentation, and audit support.
• Knowledge of TCP/IP, serial communications, interface troubleshooting, and configuration management.

Preferred Qualifications:

• Experience with Instrument Manager or comparable laboratory middleware.
• Knowledge of HL7, ASTM, GAMP 5, laboratory workflows, and quality control systems.
• Experience with audit trails, data integrity assessments, assay validation, and reportable ranges.
• Experience in clinical laboratories, pharmaceutical, biotechnology, CRO, or medical device environments.

Regulatory Knowledge:

21 CFR Part 11 • GxP • GCP • GLP • GDP • CSV • ALCOA+ • Change Control • CAPA • Deviation Management

Key Competencies:

Validation & Compliance • Data Integrity • Technical Troubleshooting • Root Cause Analysis • Documentation • Cross-Functional Collaboration • Project Coordination • Audit Readiness

Working Conditions and Environment:

• Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
• For Labs-based staff, exposure to biological fluids with potential exposure to infectious organisms.
• For Labs-based staff, personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.
• Occasional travel.
  

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands.
• Frequent mobility required.
• Occasional crouching, stooping, bending and twisting.
• Light to moderate lifting and carrying up to 15-20 lbs.
• Ability to use a variety of computer software.
• Ability to communicate information and ideas effectively, with the ability to listen to, and understand, information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Ability to multitask and perform under stress.
• Regular and consistent attendance.