Senior Validation Engineer, CSV

Location: California

Senior Validation Engineer, CSV page is loaded## Senior Validation Engineer, CSVremote type:
On-Site locations:
RTP, NCtime type:
Full time posted on:
Posted 2 Days Agojob requisition :
R04559

California, US residents .
** The job details are as follows:
** United Therapeutics Corporation seeks a Senior Validation Engineer, CSV in Durham, NC to perform the following job duties:
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.

This position requires a Master’s degree or foreign equivalent in a relevant Engineering, Science, Information Technology or Information Systems field, and 3 years of experience as a CSV Analyst, Quality Assurance Analyst, IT Compliance Analyst, Validation Engineer, Quality Assurance Engineer, or IT Compliance Engineer or a related occupation. In the alternative, employer will accept a Bachelor’s degree or foreign equivalent in a relevant Engineering, Science, Information Technology or Information Systems field, and 5 years of experience as a CSV Analyst, Quality Assurance Analyst, IT Compliance Analyst, Validation Engineer, Quality Assurance Engineer, or IT Compliance Engineer or a related occupation.

Position also requires: 3 years of domain experience acquired performing validation engineering or quality assurance engineering or information technology compliance analysis, including drafting the computer System Development Lifecycle (SDLC) documentation, for the pharmaceutical, healthcare, biomedical, or medical device industries; 24 months of combined total experience conducting computer system validation (CSV) operations such as change control activity on an Enterprise Resource Planning system such as SAP or Oracle;

12 months of combined total experience utilizing an IT Service management system such as Service Now or Remedy or Jira; and 12 months of combined total experience utilizing an Application Lifecycle Management system such as Open Text ALM or HPALM or Quality Center or ValGenesis.#LI-DNI#DE-DNIEligible 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

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…