GxP Systems Analyst - On-Site in Durham | Validation & IT

United Therapeutics Corporation; North Carolina; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Benefits package

Job summary

United Therapeutics Corporation in Durham, NC, seeks a skilled GxP Systems Analyst to support manufacturing and laboratory applications in a validated environment. You will configure software, perform validation testing, troubleshoot, upgrade and implement systems, while coordinating with vendors and internal teams to meet 21 CFR 11 requirements.

This on-site role emphasizes documentation, training, and adherence to regulatory standards.

Qualifications

• Associate degree in IT or engineering preferred with 4+ years in GxP systems.
• Bachelor’s degree in IT or engineering preferred with 2+ years in GxP systems.
• 2+ years in FDA-regulated pharma manufacturing with system administration and support.
• Experience with Level 1/2 application support.
• Experience with ticketing systems for support.
• Teamwork, communication and prioritization skills.
• Manufacturing or quality system support experience.
• Validation and change control for hardware/software.
• Experience with Teams, SharePoint, Smartsheets.
• MS SQL Server and Windows Server knowledge.
• System life-cycle project experience; requirements gathering and protocol execution.
• Experience with MasterControl, Blue Mountain RAM, Tracelink, ERP systems.
• Experience in fast-paced project teams.

Responsibilities

• Participate in system enhancements, upgrades, and new installations; configure software, validate, write SOPs, and train users.
• Provide break/fix support; troubleshoot errors; manage user accounts and maintenance.
• Coordinate with stakeholders to meet 21 CFR 11 data integrity requirements.
• Ensure continuous availability and coordinate resources during outages.
• Contribute to internal process improvements and project initiatives.
• Perform other duties as required.

Skills

GxP systems

Validation testing

Troubleshooting

Vendor liaison

Documentation

Project coordination

Team collaboration

SQL proficiency

Education

Associate degree in IT or related

Bachelor’s degree in IT or related

Tools

MS SQL Server

Windows Server

MasterControl

Blue Mountain RAM

Tracelink Serialization

Uhlmann line management

Job description

United Therapeutics Corporation in Durham, NC, seeks a skilled GxP Systems Analyst to support manufacturing and laboratory applications in a validated environment. You will configure software, perform validation testing, troubleshoot, upgrade and implement systems, while coordinating with vendors and internal teams to meet 21 CFR 11 requirements.

This on-site role emphasizes documentation, training, and adherence to regulatory standards.