GxP Systems Analyst, OT – On‑Site, Durham

United Therapeutics Corporation

Durham (NC)

On-site

USD 85,000 - 115,000

Full time

2 days ago

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Benefits offered by this job

Medical/Dental/Vision

401k and ESPP

Paid time off & parental leave

Job summary

United Therapeutics Corporation seeks a GxP Systems Analyst, Operational Technology to support manufacturing and laboratory systems in a validated, on-site environment in Durham, NC. The role covers configuration, validation testing, troubleshooting, upgrades, and end-user training, with cross-functional collaboration and vendor liaison.

The ideal candidate has 2+ years in FDA-regulated pharma environments, experience with Level 1/2 support, and familiarity with MS SQL Server, Windows Server,

Qualifications

Associate or Bachelor’s in IT/engineering with relevant GxP experience.
2+ years in FDA regulated pharmaceutical manufacturing environment.
Experience with Level 1 or 2 application support.

Responsibilities

Provide GxP application support for manufacturing and laboratory systems.
Configure, validate, troubleshoot, and upgrade systems and SOPs.
Coordinate with software vendors and internal departments on projects.

Skills

GxP systems support

MS SQL Server

Windows Server

Ticketing system

Team collaboration

Project lifecycle

SOPs training

Vendor liaison

Regulatory validation/change control

Education

Associate degree in IT/Engineering

Bachelor’s degree in IT/Engineering

Tools

MasterControl

Blue Mountain RAM

Tracelink

ER/ERP systems

Job description

The ideal candidate has 2+ years in FDA-regulated pharma environments, experience with Level 1/2 support, and familiarity with MS SQL Server, Windows Server,

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