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United Therapeutics Senior Validation Specialist/Senior Validation Engineer in Silver Spring, Maryland

The Job Details are as follows:

What we do

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 commitment to 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.

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/Senior Validation Engineer will perform activities in support of computer validation for process equipment and systems with data integrity oversight. This includes computerized information systems (LIMS), manufacturing control systems (e.g., PCS, PLC), manufacturing equipment (Fill Finish, Biologics and API) and laboratory systems.

In addition, this position will be responsible for equipment qualification and revalidation activities supporting the United Therapeutics (UT) Validation group in the generation / review / approval of validation documentation. Execution of validation studies where applicable, will be in accordance with FDA and appropriate international regulations/guidelines and latest industry practices.

  • Uses skills as an experienced professional with a full understanding of industry practices and company policies and procedures.

  • Resolves a wide range of issues whether they are equipment, computer or process related.

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

  • Participates on project teams requiring validation support. Provide technical guidance and training to company, contracted personnel other team members in various aspects of validation, data analysis, sampling techniques and other traditional areas of validation expertise.

  • Receives minimal supervision on assigned tasks and projects.

  • Develop and/or review various types of validation documentation, including but not limited to, Validation Master Plans, User Requirement and Functional Requirements Specifications, Design Specifications, Factory Acceptance Tests (FAT) and Design Qualification (DQ), IQ, OQ, PQ, PV protocols and reports.

  • Coordinate validation activities, serves as the validation subject matter expert, and serves as the lead validation person in validation projects.

  • Interface with UT system owners and contract manufacturers to assure quality and reliability of the products and processes during validation, manufacturing or transfer to manufacturing.

  • Review and approve change control requests and assess impact to validation. Initiate the necessary validation activities to support changes.

  • Provide Validation planning (both short term and long term) supporting diagnosis of validation problems and communicate identified gaps (both internal and external), implementing corrective and preventive actions to resolve those problems, and support continuous improvement of validation programs.

  • Participate in internal and regulatory agency audits

  • Other duties as assigned

For this role you will need

Minimum Qualifications

  • Senior Validation Specialist: Requires a bachelor’s degree in scientific field; or Senior Validation Engineer: Requires a bachelor’s degree in Engineering.

  • 5+ years of relevant validation experience in a pharmaceutical/cGxP environment.

  • Must be able to communicate effectively, both written and orally with colleagues, management and senior management - cross-functionally.

  • Must be able to communicate with regulatory agencies, when applicable.

  • Must be detail oriented, self-motivated, organized and have the ability to prioritize work.

  • Working knowledge of word processing, spreadsheets and basic statistical software.

Preferred Qualifications

  • Proficient in Trackwise and MasterControl

  • Prior experience with Regulatory Asset Manager

  • Proficient in Validation Datalogger Software (Amphenol / Ellab preferred)

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.

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