Senior Validation Engineer, CSV

United Therapeutics Corporation

2d

About The Position

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.

Requirements

• 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.
• 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 ServiceNow or Remedy or Jira
• 12 months of combined total experience utilizing an Application Lifecycle Management system such as OpenText ALM or HPALM or Quality Center orValGenesis

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 1,001-5,000 employees