Senior/Quality Systems Engineer, Operational Technology (LIMS)

United Therapeutics is a vaccinated work environment where all employees are expected to be vaccinated against COVID-19 and provide proof of vaccination. We will provide any accommodations as required by law.

The job details are as follows:

What We Do

United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.

We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.

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, pediatric cancers and other orphan diseases.

In 2021, we became 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.

How you’ll contribute
The Quality Systems Engineer, Operational Technology will provide technical support for various quality applications such as Labware LIMS, Empower, IDBS Electronic Laboratory Notebook, TrackWise Digital, and Laboratory Instruments in a regulated, validated environment.

Participate in project initiatives for new and existing systems. Initiatives include: enhancements or upgrades to existing systems and installation of new software applications, documenting user requirements, performing development and configuration of software, executing system and validation testing, creating/revising SOP’s, and conducting training. Collaboration with software vendors and other UT departments is critical.
Provide break/fix and administrative maintenance support for designated systems in accordance with department response time SLA’s, including, but not limited to: troubleshooting application errors, database errors, user login issues, as well as performing routine tasks such as creating user accounts, assigning access, and performing system maintenance activities and testing.
Participate in internal team initiatives and process improvement efforts
All other duties as required

A Senior Quality Systems Engineer will also:

Support and serve as the technical lead in project initiatives for new and existing systems. Initiatives include enhancements or upgrades to existing systems and installation of new software applications. Primary responsibilities include executing change controls, documenting user requirements, performing development and configuration of software, executing system and validation testing, creating/revising SOP’s, and conducting training. Collaboration with software vendors and other UT departments is critical.
Provide complex break/fix and administrative maintenance support for designated systems in accordance with department response time SLA’s, including, but not limited to: troubleshooting application errors, database errors, user login issues, as well as performing routine tasks such as creating user accounts, assigning access, and performing system maintenance activities and testing.

For this role you will need

Minimum Requirements

Bachelor’s Degree in Arts/Sciences (BA/BS) in information technology or engineering or an applicable scientific and/or engineering discipline. Will consider commensurate experience and/or combination of education and experience.
3+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on quality system administration, development, and support
Prior experience with Level 1 or 2 application support
Experience working in a computer system support environment utilizing a ticket management system to track and manage support requests
Experience in executing projects, system life-cycle process, gathering and documenting requirements, executing protocols, and understanding of methodology for execution
Work well with teams with the ability to collaborate, communicate and prioritize workload
Quality System Application support experience with Laboratory Information Management Systems (LIMS) systems, Chromatography Data Systems, Electronic Lab Notebooks (ELN), Enterprise Document Management (EDM) systems, and/or ERP systems
Completed full project lifecycle software application installations
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

Minimum Requirements - Senior Quality Systems Engineer

Bachelor’s Degree in Arts/Sciences (BA/BS) in information technology or engineering or an applicable scientific and/or engineering discipline. Will consider commensurate experience and/or combination of education and experience.
5+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on quality system administration, development, and support
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
Experience working in a computer system support environment utilizing a ticket management system to track and manage support requests
Experience in executing projects, system life-cycle process, gathering and documenting requirements, executing protocols, and understanding of methodology for execution
Work well with teams with the ability to collaborate, communicate and prioritize workload
Quality System Application support experience with Laboratory Information Management Systems (LIMS) systems, Chromatography Data Systems, Electronic Lab Notebooks (ELN), Enterprise Document Management (EDM) systems, and/or ERP systems
Completed full project lifecycle software application installations
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

Preferred Qualifications

Certified Project Management Professional (PMP)-PMI
Proficiency in SQL or Oracle Database Administration
Computer system programming and software development experience
Experience working with various standalone laboratory instruments such as FTIR, Endotoxin, HPLC, GC, HIAC, Plate Reader, etc.

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.

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