GxP Systems Analyst, Operational Technology

United Therapeutics•Rtp, NC

12h•Onsite

About The Position

The GxP Systems Analyst, Operational Technology provides application support for new and existing manufacturing and laboratory systems in a regulated, validated environment. The role supports project initiatives, including upgrades, enhancements, and new installations, as well as break/fix issues. It also acts as a liaison between software vendors and internal departments. The analyst configures software to meet user requirements, performs validation testing, creates or revises SOPs, and trains end users. The role provides application support in accordance with department response-time SLAs, helps ensure compliance with 21 CFR Part 11 and data integrity requirements, and works to maintain continuous system availability and functionality. The position is 100% on-site at United Therapeutics' Durham, North Carolina office.

Requirements

Associate degree in information technology, chemical engineering, bioengineering, or an applicable scientific or engineering discipline preferred, plus at least 4 years of experience supporting GxP systems; or a bachelor's degree in one of these fields preferred, plus at least 2 years of experience supporting GxP systems.
At least 2 years of experience in an FDA-regulated pharmaceutical manufacturing environment, emphasizing manufacturing system administration, development, and support.
Prior Level 1 or Level 2 application-support experience.
Experience in a computer-system support environment using a ticket management system to track and manage support requests.
Ability to work effectively on a team, collaborate, communicate, and prioritize workload.
Manufacturing or Quality system application-support experience.
Computer hardware/software validation and change-control experience.
Experience collaborating with tools such as Microsoft Teams, SharePoint, and Smartsheet.
Working knowledge of MS SQL Server and Windows Server.
Experience executing projects and system life-cycle processes, gathering and documenting requirements, executing protocols, and understanding execution methodology.
Experience working on small, fast-paced project teams.

Nice To Haves

Manufacturing or Quality system application-support experience with MasterControl, Blue Mountain RAM, TraceLink Serialization Management System, Uhlmann line management systems, and/or ERP systems.
Certified Project Management Professional (PMP) through PMI.
System integration experience using tools such as Dell Boomi.
Experience with standalone laboratory instruments such as FTIR, endotoxin testing systems, HPLC, GC, HIAC, or plate readers.
Experience completing the full project lifecycle for software application installations.
Computer system programming and software development experience.
Proficiency in SQL or Oracle Database Administration.

Responsibilities

Participate in system enhancement, upgrade, and new-installation projects.
Configure software to meet user requirements, execute validation testing, create or revise SOPs, and train end users.
Collaborate with software vendors and internal departments to meet project timelines.
Provide break/fix support for designated systems in accordance with department response-time SLAs.
Troubleshoot application errors, database errors, and user login issues.
Create user accounts, assign access, and perform system maintenance activities and testing.
Work with internal stakeholders to meet 21 CFR Part 11 requirements and data integrity requirements.
Help ensure continuous, uninterrupted availability and functionality of computer systems, and coordinate resources for outages and emergencies.
Participate in internal team initiatives and process-improvement efforts.
Perform other duties as required.