GxP Systems Analyst, Operational Technology

United Therapeutics Corporation; North Carolina; Vor Ort; USD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Benefits package

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

GxP systems

Validation testing

Troubleshooting

Vendor liaison

Documentation

Project coordination

Team collaboration

SQL proficiency

Ausbildung

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

Jobbeschreibung

California, US residents click here.

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

You’re an experienced systems analyst who understands the unique demands of supporting GxP applications in manufacturing and laboratory environments. You bring hands‑on experience with application configuration, validation testing, troubleshooting, upgrades, enhancements, and system implementations. You’re equally comfortable investigating a break/fix issue, contributing to a project initiative, training end users, or coordinating with a software vendor. You’re organized, collaborative, and able to balance technical requirements, business needs, and the documentation and rigor required in a validated environment.

The GxP Systems Analyst, Operational Technology will provide application support for the new and existing manufacturing and laboratory systems. This will include project initiatives such as upgrades, enhancements, and new installations as well as break / fix support in a regulated, validated environment. This position will also include liaising between software vendors and internal departments.

• Participate in project initiatives such as system enhancements, upgrades, and new installations. Configure the software to meet user requirements, execute the validation testing, create/revise SOPs, and train the end users. Collaborate with software vendors and other UT departments to meet project timelines.
• Provide break/fix support for designated systems in accordance with department response time SLAs to include, but not limited to, troubleshooting application errors, database errors, and user login issues as well as performing routine tasks such as creating user accounts, assigning access, and performing system maintenance activities and testing
• Work with other internal stakeholders to meet 21cfr11 computer regulations and all required data integrity requirements.
• Ensure the continuous, uninterrupted availability and functionality of computer systems, and coordinate appropriate resources to respond to outages and emergencies
• Participate in internal team initiatives and process improvement efforts
• All other duties as required

Minimum Requirements

• Education and Experience requirements:
  • Associate degree in information technology, chemical engineering, bioengineering or an applicable scientific and/or engineering discipline preferred, and 4+ years of experience supporting GxP systems, or
  • Bachelor’s degree in information technology, chemical engineering, bioengineering or an applicable scientific and/or engineering discipline preferred, and 2+ years of experience supporting GxP systems
• 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 2 application support
• Prior experience working in a computer system support environment utilizing a ticket management system to track and manage support requests
• Ability to work well in a team environment and 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 Smartsheets
• Working knowledge of MS SQL Server and Windows Server
• Experience in executing projects, system life-cycle process, gathering and documenting requirements, executing protocols, and understanding of methodology for execution
• Manufacturing or Quality System Application support experience with MasterControl, Blue Mountain RAM, Tracelink Serialization Management System, and Uhlmann line management systems, and/or ERP systems
• Experience working on small, fast paced project teams

Preferred Qualifications

• Certified Project Management Professional (PMP)-PMI
• System integration experience using tools such as Dell Boomi
• Experience working with various standalone laboratory instruments such as FTIR, Endotoxin, HPLC, GC, HIAC, Plate Reader, etc.
• Experience completing full project lifecycle software application installations
• Computer system programming and software development experience
• Proficiency in SQL or Oracle Database Administration

Job Location

United Therapeutics requires this role to be 100% on‑site at our Durham, NC office.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.