United Therapeutics Senior Validation Specialist (Engineer) in Durham, North Carolina

The Job Details are as follows:

What we do

United Therapeutics is a biotechnology company that focuses on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions. We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them. Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.

How you’ll contribute

The Senior Validation Specialist will perform duties as the lead validation engineer for process and cleaning validation and advise on aseptic validation activities in both solid dose and sterile operations at multiple UT sites.

  • Develops and maintains the programmatic aspects of the process and cleaning validation functions

  • Advise on the structure and documentation of aseptic practices

  • Leads execution of all process and cleaning validation functions and provides guidance to validation engineers and technicians providing execution assistance

  • Supports periodic reviews of cleaning and aseptic processes

  • Uses skills and professional experience with a full understanding of regulatory guidance and industry practices to develop procedures

  • Works collaboratively with other UT sites to harmonize and optimize cleaning and process validation practices

  • Uses experience in root cause analysis during process deviations

  • Provides general support to the Validation organization to meet department goals and objectives

  • Participates on project teams requiring validation support

  • Participates in the preparation or review of master plans, protocols and reports supporting validation

  • Receives minimal supervision on assigned tasks and projects

  • Participates in regulatory audits supporting auditor’s requests. May be asked to interact directly with auditors in respect to validation function

For this role you will need

Minimum Qualifications

  • Bachelor of Science in Engineering and 5+ years of validation experience; or a Bachelors degree in a Life Science discipline and 9+ years validation experience

  • Working Knowledge of regulatory requirements from USFDA and EU

  • Up to 25% travel

Preferred Qualifications

  • Proficient in Microsoft Office and basic statistical software

  • Detail oriented, self-motivated, organized and have the ability to prioritize work

  • Ability to communicate effectively, both written and orally with colleagues, management and senior management - cross-functionally

  • Ability to communicate with regulatory agencies, when applicable

  • Ability to work with minimal supervision

Life as a Unitherian

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. 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 of job performance and provides state of the art facilities to flourish. This is what makes United Therapeutics a stimulating place to work.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

United Therapeutics currently has five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high level job performance, and provide state of the art facilities in which to flourish. This is what makes United Therapeutics a stimulating place to work. 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.