GxP Systems Analyst / Senior GxP Systems Analyst, Operational Technology

The job details are as follows:

What We Do

We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.

How you’ll contribute
The GxP Systems Analyst, Operational Technology will provide application support for the manufacturing systems such as Optel and Uhlmann line management systems; MasterControl; Blue Mountain RAM; or TraceLink. This will include project initiatives such as upgrades, enhancements, and new installations as well as break / fix support in a regulated, validated environment. This role will be required to perform various aspects of the project lifecycle including configuring the software, executing the validation testing, and training the end users.

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
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

The Senior GxP Systems Analyst, Operational Technology will serve as the technical lead in assigned project initiatives for new and existing manufacturing systems.

Serve as the technical lead in assigned project initiatives for new and existing systems. Initiatives include enhancements or upgrades to existing systems and installation of new software applications. Primary responsibilities include the following: creating and executing change controls to meet project timelines, documenting user requirements, performing development and configuration of software, executing system and validation testing, creating/revising SOPs, conducting training, and coordinating project activities with software vendors and other UT departments.

For this role you will need

Minimum Requirements

Bachelor’s Degree in Arts/Sciences (BA/BS) in information technology, chemical engineering, bioengineering or an applicable scientific and/or engineering discipline preferred; will consider commensurate experience and/or combination of education and experience
GxP Systems Analyst, Operational Technology: 3+ years of experience supporting GxP systems
GxP Systems Analyst, Operational Technology: 3+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on manufacturing system administration, development and support
Senior GxP Systems Analyst, Operational Technology: 5+ years of experience supporting GxP systems
Senior GxP Systems Analyst, Operational Technology 5+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on manufacturing system administration, development, and support
Senior GxP Systems Analyst, Operational Technology: Experience as technical lead on projects and with system life-cycle process, gathering and documenting requirements, executing protocols, and understanding of methodology for execution
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 with the ability to collaborate, communicate and prioritize workload
Manufacturing 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 working on small, fast paced project teams
Experience in executing projects, system life-cycle process, gathering and documenting requirements, executing protocols, and understanding of methodology for execution
Manufacturing System Application support experience with MasterControl, Blue Mountain RAM, Tracelink Serialization Management System, Optel and Uhlmann line management systems, and/or ERP systems
Experience completing full project lifecycle software application installations

Preferred Qualifications

Certified Project Management Professional (PMP)-PMI
System integration experience using tools such as Dell Boomi
Computer system programming and software development experience
Proficiency in SQL or Oracle Database Administration

At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.

While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities