United Therapeutics Corporation · 8 hours ago
GXP Systems Analyst, Operational Technology
Silver Spring, MD
Full-time
Onsite
Mid Level
$77K/yr - $107K/yr
4+ years expUnited Therapeutics Corporation is a publicly-traded biotech company focused on developing novel pharmaceutical therapies and technologies for transplantable organs. The GXP Systems Analyst, Operational Technology will provide application support for manufacturing and laboratory systems, including project initiatives, break/fix support, and compliance with regulations.
BiotechnologyPharmaceuticalTherapeutics
Hiring Manager
William Neutzling
Responsibilities
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
Qualification
Required
Associate Degree in information technology, chemical engineering, bioengineering or an applicable scientific and/or engineering discipline preferred OR Bachelor's Degree in information technology, chemical engineering, bioengineering or an applicable scientific and/or engineering discipline preferred
4+ years of experience supporting GxP systems with an Associate Degree OR 2+ years of experience supporting GxP systems with a Bachelor's Degree
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
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
Benefits
Medical / dental / vision / prescription coverage
Employee wellness resources
Savings plans (401k and ESPP)
Paid time off & paid parental leave benefits
Disability benefits
Company
United Therapeutics Corporation
Founded to find a cure for a daughter’s rare disease, United Therapeutics is a biotechnology company transforming care for people with chronic and life-threatening conditions.
1001-5000 employees
H1B Sponsorship
United Therapeutics Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (13)
2023 (8)
2022 (6)
2021 (9)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
unknown1999-06-17IPO
Leadership Team
Hamlet Bonilla Evertsz
Senior Network Engineer
Recent News
2025-12-29
NH Business Review
2025-11-11
Company data provided by crunchbase