GxP Systems Analyst / Senior GxP Systems Analyst, Operational Technology
Company: United Therapeutics
Location: Wilmington
Posted on: May 6, 2024
Job Description:
California, US residents click here.
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
Keywords: United Therapeutics, Jacksonville , GxP Systems Analyst / Senior GxP Systems Analyst, Operational Technology, IT / Software / Systems , Wilmington, North Carolina
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