Experience Inc. Jobs

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:

Position Overview

Full Time Professional Position Located in Durham, North Carolina

Key Accountabilities / Responsibilities

Apply specialized knowledge of computer system validation practices including deliverables and risk assessments for enterprise data systems for manufacturing, purchasing, planning, IT Infrastructure, clinical safety, quality control laboratory, clinical data management, regulatory, and quality operations. Evaluate operational requirements and develop test plans, test cases, and test protocols to govern the controlled implementation of computerized systems by delivering: Installation Qualification (IQ) protocols, Operational Qualification (OQ) protocols, Performance Qualification (PQ) protocols, User Acceptance Test (UAT) protocols, Data Migration (DM) protocols, Regression Test (RT) protocols. Work with specialized teams to perform collaboration, approval, oversight, test execution, discrepancy management, and generation of final reports in accordance with project timelines. Determine test approaches based on a risk assessment process. Prepare plans, specifications, protocols, discrepancy reports, and summary reports. Design and perform data migration activities including determination of sample sizes based on ASQ AQL, conducting electronic Source/Target data comparisons, and visual comparison of results. Collect, compile, and review data in support of validation test cases or validation studies. Conduct risk assessments of established functional requirements as required. Apply full understanding of the validation best practices, as well as the organization’s policies and procedures to contribute to project team activities; represent Validation interests on project teams, interact with hosting vendors and contractors, prepare validation change control request records, and conduct periodic reviews. Determine prospective and regression testing approaches based on a risk assessment process. Participate in the preparation or review of protocols and reports supporting the validation of equipment, systems, and processes; develop, execute, and summarize the execution of validation protocols; support the collection, compilation, and review of data in support of validation studies; and lead validation change control activities.

TO APPLY: applications may be made through this Careers Page through March 13, 2025 thereafter resumes may be mailed to: United Therapeutics, Attn: A. Wise - R04008, 55 TW Alexander Drive, Durham, NC 27709. Please reference Job Posting R04008.

Minimum Education and Experience Required

Master’s degree in a relevant engineering, science, information technology or information systems field with three years of experience as a Validation Engineer, Quality Assurance Engineer, or Computer Systems Validation Analyst. As an alternative, a Bachelor’s degree in a relevant engineering, science, information technology or information systems field with at least five years of experience as a Validation Engineer, Quality Assurance Engineer, or Computer Systems Validation Analyst will be acceptable

Knowledge, Skills, and Abilities

3 years of domain experience acquired performing validation or quality assurance engineering or analysis within the pharmaceutical, biomedical, or medical device industries.

3 years of experience conducting CSV validation operations on the industry standard business platforms: SAP ERP; SAP Success Factors; Veeva CTMS, Veeva Clinical; Argus.

3 years of experience with any three of the following industry standard platforms: OpenText ALM; TrackWise; MasterControl; SAP ERP Manufacturing, Purchasing; ServiceNow.

#LI-DNI

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

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and 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.