GxP Systems Analyst / Senior GxP Systems Analyst, Operational Technology - United Therapeutics
Durham, NC
About the Job
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .
The job details are as follows:
How You’ll Contribute
The GxP Systems Analyst, Operational Technology will provide application support for Manufacturing and Quality 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 software, executing validation testing, and training end users.
+ Perform configuration and development of the software to meet user requirements, execute validation testing, create/revise SOPs, and train the end users.
+ Participate in project initiatives such as system enhancements, upgrades, and new installations.
+ 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.
+ Collaborate with software vendors and other UT departments to meet project timelines.
+ All other duties as required.
_In addition to the above duties, the Senior GxP Systems Analyst, Operational Technology will:_
+ Serve as the technical lead on assigned project initiatives.
+ Create and execute change controls to meet project timelines.
+ Collaborate with Validation to draft protocols such as Design Specifications and Installation/Operation/Performance Qualifications.
For this role you will need
Minimum requirements
+ Bachelor’s degree 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
+ System Application support and development experience with Labware LIMS including Software Configuration, Administration, Master Data, LIMS Basic development, and Electronic Laboratory Notebook (ELN) development.
+ Experience collaborating with tools such as Microsoft Teams, SharePoint and Smartsheet
+ Working knowledge of MS SQL Server and Windows Server
+ 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.
+ Computer hardware / software validation and change control experience.
+ Experience working on small, fast-paced project teams.
+ Experience in executing projects, gathering and documenting requirements, executing protocols, and understanding of methodology for execution.
+ Experience completing full project lifecycle software application installations.
GxP Systems Analyst, Operational Technology:
+ 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
Senior GxP Systems Analyst, Operational Technology:
+ 5+ years of experience supporting GxP systems
+ 5+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on manufacturing 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
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
+ System Application support experience with one or more of the following: MasterControl, Blue Mountain RAM, Empower, OpsTrakker, and Trackwise Digital.
+ Development experience with tools such as Crystal Reports, JavaScript, Microsoft SQL Server, and PowerShell
+ Experience creating and running validation documentation
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
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
The job details are as follows:
How You’ll Contribute
The GxP Systems Analyst, Operational Technology will provide application support for Manufacturing and Quality 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 software, executing validation testing, and training end users.
+ Perform configuration and development of the software to meet user requirements, execute validation testing, create/revise SOPs, and train the end users.
+ Participate in project initiatives such as system enhancements, upgrades, and new installations.
+ 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.
+ Collaborate with software vendors and other UT departments to meet project timelines.
+ All other duties as required.
_In addition to the above duties, the Senior GxP Systems Analyst, Operational Technology will:_
+ Serve as the technical lead on assigned project initiatives.
+ Create and execute change controls to meet project timelines.
+ Collaborate with Validation to draft protocols such as Design Specifications and Installation/Operation/Performance Qualifications.
For this role you will need
Minimum requirements
+ Bachelor’s degree 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
+ System Application support and development experience with Labware LIMS including Software Configuration, Administration, Master Data, LIMS Basic development, and Electronic Laboratory Notebook (ELN) development.
+ Experience collaborating with tools such as Microsoft Teams, SharePoint and Smartsheet
+ Working knowledge of MS SQL Server and Windows Server
+ 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.
+ Computer hardware / software validation and change control experience.
+ Experience working on small, fast-paced project teams.
+ Experience in executing projects, gathering and documenting requirements, executing protocols, and understanding of methodology for execution.
+ Experience completing full project lifecycle software application installations.
GxP Systems Analyst, Operational Technology:
+ 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
Senior GxP Systems Analyst, Operational Technology:
+ 5+ years of experience supporting GxP systems
+ 5+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on manufacturing 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
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
+ System Application support experience with one or more of the following: MasterControl, Blue Mountain RAM, Empower, OpsTrakker, and Trackwise Digital.
+ Development experience with tools such as Crystal Reports, JavaScript, Microsoft SQL Server, and PowerShell
+ Experience creating and running validation documentation
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
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
Source : United Therapeutics