United Therapeutics Senior Validation Specialist in Durham, North Carolina
The Job Details are as follows:
What we do
About United Therapeutics
United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our obsession with quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens — having a positive impact on patients, the environment and society — will sustain our success in the long term. Through our wholly-owned subsidiary, Lung Biotechnology PBC, we are focused on addressing the acute national shortage of transplantable lungs and other organs with a variety of technologies that either delay the need for such organs or expand the supply. Lung Biotechnology is the first public benefit corporation subsidiary of a public biotechnology or pharmaceutical company. 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 – Computer System Validation will perform activities in support of validated computerized systems including the periodic review, and continuous maintenance of both hosted, global enterprise, and local computer systems. Responsible for preparing specifications, protocols and final reports, and preparing change control requests.
Performs periodic reviews of computer system validation status
Risk assess and determines prospective and regression testing during the routine software updates conducted in-house and provided by Software as a Service vendors.
Supports change control activities.
Provides deviations investigation and resolution for issues discovered during the course of validation work
Supports the onboarding and validation of new enterprise computer system software applications.
Provides general support to the Validation organization to meet department goals and objectives.
Participates on project teams requiring validation support.
Provides training to company and contracted personnel on validation policies and procedures.
Develop, execute and summarize the execution of validation protocols.
Assists team in collecting, compiling and reviewing data in supports of validation studies.
For this role you will need
Bachelors Degree in Engineering, Life Sciences or equivalent experience in Validation
5+ years of relevant validation experience in a pharmaceutical/cGMP environment with some experience in computer system validation
Must be able to communicate effectively, both written and orally with colleagues, management and senior management - cross-functionally. Additionally, must be able to communicate with regulatory agencies, when applicable
Up to 15% travel
Proficient in Microsoft Office (Word, Excel, Outlook)
Proficient in SAP, Veeva, DocuSign, Blue Mountain, TrackWise, and MasterControl computer
Working knowledge of US and international regulations related to validation activity is required
Must be detail oriented, self motivated, organized and have the ability to prioritize work
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.