GXP Systems Analyst, Operational Technology

Unither Pharmaceuticals•Silver Spring, MD

13d•$77,000 - $10,700•Onsite

About The Position

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. You're excited about supporting our internal stakeholders as we look to implement new technology solutions that help make their lives easier. You have a strong attention detail and managing the change control process is second nature to you. 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 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 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

Requirements

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

Nice To Haves

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

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

Benefits

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

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