GxP Systems Analyst, Operational Technology

United Therapeutics Corporation•RTP, NC, NC

2d•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, and serves as a liaison between software vendors and internal departments. The analyst configures software to meet user requirements, performs validation testing, creates or revises SOPs, trains end users, and collaborates with vendors and internal departments to meet project timelines. The role also supports system availability and functionality, works with stakeholders on regulatory and data-integrity requirements, and contributes to team initiatives and process improvements. This position is 100% onsite at the company’s Durham, North Carolina office.

Requirements

Associate degree in information technology, chemical engineering, bioengineering, or an applicable scientific or engineering discipline preferred, plus 4 or more years of experience supporting GxP systems; or a bachelor’s degree in one of these disciplines preferred, plus 2 or more years of experience supporting GxP systems.
At least 2 years of experience in an FDA-regulated pharmaceutical manufacturing environment, with emphasis on manufacturing system administration, development, and support.
Prior experience with Level 1 or Level 2 application support.
Prior experience working in a computer system support environment that uses a ticket management system to track and manage support requests.
Ability to work well in 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.
Manufacturing or Quality System Application support experience with MasterControl, Blue Mountain RAM, TraceLink Serialization Management System, Uhlmann line management systems, and/or ERP systems.
Experience working on small, fast-paced project teams.

Nice To Haves

Certified Project Management Professional (PMP) from PMI.
System integration experience using tools such as Dell Boomi.
Experience working with standalone laboratory instruments such as FTIR, endotoxin, HPLC, GC, HIAC, and plate readers.
Experience completing full project-lifecycle 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 within department response-time SLAs, including troubleshooting 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 computer regulations and required data-integrity requirements.
Ensure continuous, uninterrupted availability and functionality of computer systems, coordinating resources to respond to outages and emergencies.
Participate in internal team initiatives and process-improvement efforts.
Perform other duties as required.